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Adverse Event Report

C.R. BARD INC. BARD FOLEY CATHETER   back to search results
Event Description

Complainant reported his 92 year old father was admitted to hosp on 10/5/99, for congestive heart disease. A catheter was inserted. Complainant said he was not aware his father had urinary problems. When it was time to remove the catheter, it had to be removed surgically because it would not come out. After 10 days, he was sent home. He was home only one day when he had to return to the hosp because he could not urinate. Again he was scheduled for another surgical procedure and another catheter was inserted. According to the rptr the urologist told the pt that the first catheter, which he had not inserted, was defective. The urologist said he had to remove the balloon from his bladder, which apparently had remained in the pt when the catheter was removed. Complainant was not sure exactly what he was talking about. After a 3 day stay in the hosp, he was transferred to a rehabilitation center, which is where he now is. Complainant said his father is now very weak and cannot walk and is having trouble urinating. They have hired a nurse around the clock to take care of him. Investigator placed a call to the urologist. He was busy with pts, but would return investigator's call. On 11/10 dr called investigator. He explained as follows: the pt was admitted for congestive heart disease. Because he was being given diuretics, a catheter was inserted. Once the pt was better, the nurse tried to remove the catheter but could not. The dr who is a urologist, was asked to assist. Said the balloon would not deflate. Several attempts were made at bedside to deflate the balloon but to no avail. The pt was then taken to surgery and a cystoscopy was peformed. The balloon could never be deflated. It was removed in the inflated state. Dr said he told the hosp to keep the defective catheter so it could be shown to the mfr along with the incident report. Dr said he heard mention that this had also happened once or twice earlier in the week. The only thing he could tell investigator was that the catheter was a bard catheter. He did not have info on the lot number. Dr said the pt is 92 years old, with diabetes and many medical problems. He is now in a rehabilitative center and being treated for problems with urinating. Investigator called the hosp and spoke to the risk mgr. She said an incident report had been provided to the co and would pull the report. Unfortunately, the packaging had been discarded, so she did not know if the lot number was available. Investigator asked about remaining stock. She said that at the time of the incident all bard catheters were removed from the shelf and replaced with new ones. Investigator asked her if she was aware of this problem happening earlier in the week. She said she did recall a similar problem; but the catheter was removed successfully without incident to the pt. On 11/15/99, risk mgr called to get investigator's fax number. She faxed a copy of the mandatory medwatch form which she had completed. Unfortunately, lot numbers, serial numbers and expiration dates were not available, because the packaging had been discarded.

 
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Brand NameBARD FOLEY
Type of DeviceCATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
C.R. BARD INC.
8195 industrial blvd.
covington GA 30209
Device Event Key244212
MDR Report Key252161
Event Key236383
Report NumberMW4002636
Device Sequence Number1
Product CodeKOD
Report Source Voluntary
Report Date 10/29/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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