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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP DRAIN,FLAT,10X4MM,PERFORATED FLAT WOUND DRAIN   back to search results
Model Number SU130-1311
Event Date 05/17/2001
Event Type  Malfunction  
Manufacturer Narrative

Visual inspection of the two product samples that were received confirmed they were catalog number su 130-1311, jp 10mm flat silicone drain full length perforated and each one was attached to a 100cc reservoir. Both drain samples have black suture thread tied around the silicone tube at approx 1. 50 inches from drain/tubing junction area. Microscopic examination revealed wavy/jagged edges at the fracture sites and no distortion in the adjacent drain which indicates that the drain was not stretched (elongated) to failure. The characteristics of the fractured area and the absence of any tubing distortion are similar to those failures which may have been caused by nicks or puncture by a sharp instrument. Another observation in the clear tubing of one sample demonstrated a small cut that passes through one side of the wall of the tubing (not associated with the fracture site) at approx 0. 20 inches from the break site which indicates that the unit was cut with a sharp instrument. While this analysis cannot conclusively determine the cause for failure, the observations do not lead us to believe that there was in inherent weakness in the material itself. Moreover, it cannot be concluded with any certainty when or where the drain caution should be taken when using these drains. To facilitate later removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured either internally or externally. Drains should be placed and removed carefully by hand only with a slow steady pressure. Excessive force may result in breakage. Drains or tubing should not be handled with any instruments because this can lead to tearing, warping, or weakening and subsequent breakage of the drain.

 
Event Description

The drain broke off inside the pt as they were removing the drain. Pt was taken back into surgery.

 
Manufacturer Narrative

The product sample has not been received for evaluation. When the sample becomes available an evaluation will be performed. A follow-up report will be filed upon receipt of investigation results.

 
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Brand NameDRAIN,FLAT,10X4MM,PERFORATED
Type of DeviceFLAT WOUND DRAIN
Baseline Brand NameDRAIN,FLAT,10X4MM,PERFORATED,
Baseline Generic NameWOUND DRAIN
Baseline Model NumberSU130-1311
Baseline Device FamilyWOUND DRAIN
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/26/1976
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 Contact
patricia sharpe-gregg
1500 waukegan rd
mcgaw park , IL 60085
(847) 578 -3636
Device Event Key327733
MDR Report Key338429
Event Key316413
Report Number1423507-2001-00174
Device Sequence Number1
Product CodeGCY
Report Source Manufacturer
Source Type User facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/19/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL NumberSU130-1311
Device Catalogue NumberSU130-1311
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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