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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER; SILASTIC CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER; SILASTIC CATHETER Back to Search Results
Model Number 33616
Device Problems Material Rupture (1546); Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that the balloon of the catheter allegedly ruptured during patient use.Per additional information received via email on 27 feb 2020 from ibc representative, a piece of the balloon was missing.The piece could not be found.There was no reported patient injury.Per additional information received via email on 2 march 2020 from ibc representative, there was no procedure performed to locate the missing piece.There is no injury to the patient.
 
Event Description
It was reported that the balloon of the catheter allegedly ruptured during patient use.Per additional information received via email on 27 feb 2020 from ibc representative, a piece of the balloon was missing.The piece could not be found.There was no reported patient injury.Per additional information received via email on 2 march 2020 from ibc representative, there was no procedure performed to locate the missing piece.There is no injury to the patient.
 
Manufacturer Narrative
The reported event was confirmed, but the root cause is unknown.A used silastic catheter was returned with portions of the balloon missing.A potential root cause of the reported event could be "high modulus latex".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
BARD® SILASTIC® FOLEY CATHETER
Type of Device
SILASTIC CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9824571
MDR Text Key186697560
Report Number1018233-2020-01779
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741020063
UDI-Public(01)00801741020063
Combination Product (y/n)N
PMA/PMN Number
K951103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2021
Device Model Number33616
Device Catalogue Number33616
Device Lot NumberMCCV1623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Date Manufacturer Received04/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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