MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER; SILASTIC FOLEY CATHETER

Model Number 33618

Device Problems Misassembled (1398); Failure to Align (2522)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 inflation cap was misaligned on one of the catheters.

Manufacturer Narrative

The reported event was confirmed.Seven unopened silastic catheters were returned.A third catheter was opened and it was found that the catheter's drainage funnel appeared to be poorly trimmed.The catheter was inflated with air and passively deflated with no issues.The same process was repeated with 10ccs of water and initially no water returned.The syringe was screwed further and the balloon passively deflated with no issues.Upon closer examination it was found that the catheter cap was misaligned.A potential root cause for this failure could be "dipping too shallow - incorrect fluid level in the slurry tank".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: ¿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.

Event Description

It was reported that the inflation cap was misaligned on one of the catheters.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9641306
• MDR Text Key: 184139855
• Report Number: 1018233-2020-00571
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070
• Combination Product (y/n): N
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 33618
• Device Catalogue Number: 33618
• Device Lot Number: NGDS0376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1