MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INTERMITTENT FEMALE CATHETER

Model Number	015914
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the catheter had two holes instead of one which resulted in a patient experiencing a urine leak.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿incorrect tooling¿ with a potential root cause of ¿operator error¿.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: " starting at the top of the package, peel down to expose the catheter.Holding the labia apart with one hand, take the catheter and insert the tip of the catheter slowly into the urethra.If sitting on a toilet seat, once the tip of the catheter is in the bladder, allow the urine to flow directly into the toilet bowl.If on a chair or in bed, use a receptacle for urine collection.".
Event or Problem Description
It was reported that the catheter had two holes instead of one which resulted in a patient experiencing a urine leak.No medical intervention was reported.

• Brand Name: BARD® INTERMITTENT FEMALE CATHETER
• Common Device Name: FEMALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9374900
• Report Number: 1018233-2019-07539
• Device Sequence Number: 2499457
• Product Code: KOD
• UDI-Device Identifier: 00801741039027
• UDI-Public: (01)00801741039027
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 015914
• Device Catalogue Number: 015914
• Device Lot Number: NGCZ3830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1