MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP; FOLEY CATHETER (LATEX)

Model Number	0168L18
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
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 catheter fell out a few days after the placement due to a water leak.Per sample evaluation, it was found that the catheter had a asymmetrical balloon, and degradation was also found on the catheter.
Event or Problem Description
It was reported that the catheter fell out a few days after the placement due to a water leak.Per sample evaluation, it was found that the catheter had a asymmetrical balloon, and degradation was also found on the catheter.
Additional Manufacturer Narrative
The reported event was confirmed.An orange lubricath coude catheter was returned without its original packaging.There was white markings on the catheter balloon and tip area which appear to be indicative of a degradation.A 10cc leur lock syringe was used to inflate the catheter with 10 ccs of air.The balloon appeared to be asymmetric.The catheter was then passively deflated with no issues.Then the catheter was inflated again with 10 ccs of water.The balloon appeared to be asymmetric.The catheter's balloon was out specification as per inspection procedure due to the asymmetry of the balloon when inflated with water and when inflated with air was greater than 60/40.A potential root cause for this failure could be "balloon molding".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed as the reported event cannot be caused by the user.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® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9632970
• Report Number: 1018233-2020-00513
• Device Sequence Number: 3153591
• Product Code: EZC
• UDI-Device Identifier: 00801741017834
• UDI-Public: (01)00801741017834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 01/24/2024
• Device Model Number: 0168L18
• Device Catalogue Number: 0168L18
• Device Lot Number: MCDN4233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1