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

Model Number 0165SI14

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

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 syringe inserted to inject the water from the inflation valve and the valve came off from the catheter.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Evaluation on the exterior of the sample found the cap was detached from inflation funnel.The edges of the inflation funnel were smooth and regular.The cap able to re-connect to the funnel.How and when the event occurred could not be determined.Potential root cause for this failure mode could funnel thickness incorrectly sized at build-up or finish dipping operations/ machine misalignment during valve/cap assembly/user related (rough handling).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: "direction of use; using aseptic technique, position the needle-less syringe(slip-tip or luer-lock type) in the center of sampling port.The syringe should be held perpendicular to the surface of the sampling port.Press the syringe and twist to lock the syringe onto the sampling port attached luer tip syringe to the inflation valve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.If situation wouldn't be improved, serve the inflation funnel of valve." 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 syringe inserted to inject the water from the inflation valve and the valve came off from the catheter.

• Brand Name: BARDEX I.C. 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: 10845570
• MDR Text Key: 217726751
• Report Number: 1018233-2020-06347
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 0CD118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1