MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)

Model Number 165814

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 08/11/2020

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 catheter difficult to deflate during the pretest.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Visual inspection noted one two-way silicone foley catheter was received.Visual evaluation noted there was solution in the balloon on return.Through the clear solution, it could be seen that the inflation notch was not perforated correctly.The punch for the inflation notch was deep enough to penetrate into the drainage lumen, but the piece of silicone was never removed from the device.The balloon was dissected to confirm that the inflation notch was not perforated correctly.This is considered a failure, stating that the notch punch should be complete.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be missing notch perforation/notch marked only and flash still attached to the piece.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.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 catheter difficult to deflate during the pretest.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10526259
• MDR Text Key: 207730002
• Report Number: 1018233-2020-05870
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745
• Combination Product (y/n): N
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165814
• Device Catalogue Number: 165814
• Device Lot Number: NGDU2298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1