MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; 3 WAY FOLEY CATHETER

Model Number	73016SI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the inflation valve became detached during use.The user tried to deflate the balloon by using a blunt tip needle in the inflation lumen to no avail.The user then contacted medical services who advised to involve the urologist and discussed possible ways for deflation.In the end mineral oil was employed to degrade the balloon and the catheter was removed successfully.No further medical intervention required.
Event or Problem Description
It was reported that the inflation valve became detached during use.The user tried to deflate the balloon by using a blunt tip needle in the inflation lumen to no avail.The user then contacted medical services who advised to involve the urologist and discussed possible ways for deflation.In the end mineral oil was employed to degrade the balloon and the catheter was removed successfully.No further medical intervention required.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging), used two way silicone foley.It was noted that the inflation arm was broken off of the catheter with jagged edges, while the inflation valve was still in place.Cuts, holes or tears in arms are not allowed per inspection procedure.The catheter funnel was cut open to examine whether the catheter was properly cured due to a slight discoloration of the catheter.If the catheter was too soft, had channels or felt too much like liquid then the catheter would not have been properly cured.However, the catheter felt stiff as normal and was cut cleanly as usual, likely indicating the curing was properly done.In addition, it was noted that there was significant flash on the outside of the drainage funnel, causing a change in appearance.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be excess of temperature in the funnel.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." 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: 3 WAY FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9621724
• Report Number: 1018233-2020-00489
• Device Sequence Number: 19621328
• Product Code: MJC
• UDI-Device Identifier: 00801741025488
• UDI-Public: (01)00801741025488
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2023
• Device Model Number: 73016SI
• Device Catalogue Number: 73016SI
• Device Lot Number: NGCW1843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1