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

Model Number 165812

Device Problems Material Invagination (1336); Structural Problem (2506)

Patient Problems No Consequences Or Impact To Patient (2199); 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 during evaluation that a ridge/cuff was present on the balloon of the catheter.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted that the inflation valve had been cut off (likely by the complainant in an attempt to deflate the catheter) and the catheter balloon had a visible ridge on sample receipt.This is out of specification, which stated, "cap and valve must be present" and "balloon must not cuff after deflation." the catheter balloon was dissected and it was found that the inflation notch was not completely perforated.This was out of specification per inspection procedure, which stated, "verify that the eye and notch punches are complete and in within the applicable drawing for each fr.Size." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate pressure on the machine to punch.¿ 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 syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, 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.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 during evaluation that a ridge/cuff was present on the balloon of the catheter.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10017836
• MDR Text Key: 189877378
• Report Number: 1018233-2020-02957
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 165812
• Device Catalogue Number: 165812
• Device Lot Number: NGCZ2376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1