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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. FOLEY CATHETER, 18FR, 30CC   back to search results
Model Number 2D2641
Event Date 08/13/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The catheter was placed through the skin into the kidney following a stag horn calcification removal. Excessive bleeding was noticed at insertion site. The catheter was removed. After removal, it was observed that the volume of water in the balloon was less than 30 cc. Upon closer examination, a hole was observed on the shaft of the catheter. Balloon water leakage was noted from that hole. The pt required a blood transfusion related to the blood loss. Add'l length of stay in the hosp was incurred related to this complication. The doctor was not convinced that the partial balloon deflation caused the excessive bleeding since it was also possible that the pt pulled on the catheter.

 
Manufacturer Narrative

Balloon could be easily inflated with 35cc of air via a luer tip syringe and remained intact when kept aside for 30 minutes. The nylon thread was removed and entire catheter shaft with the balloon inflated with air was immersed in a beaker of water. No leak was observed. No defect could be detected. Product is fully functional when tested.

 
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Brand NameFOLEY CATHETER, 18FR, 30CC
Type of DeviceCATHETER
Baseline Brand NameFOLEY CATHETER, 18FR, 30CC
Baseline Generic NameCATHETER
Baseline Catalogue Number2D2641
Baseline Model Number2D2641
Other Baseline ID NumberUNK
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section G)
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park IL 60085
Device Event Key116530
MDR Report Key118854
Event Key111774
Report Number1423537-1997-00178
Device Sequence Number1
Product CodeKOD
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 09/11/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2D2641
Device Catalogue Number2D2641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/1997
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received08/18/1997
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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