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

Model Number	015914
Health Effect - Clinical Code	Pain (1994)
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 patient stated the catheters hurt and caused her pain when she inserted it.
Event or Problem Description
It was reported that the patient alleged the catheters hurt and caused her pain when she inserted it.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿difficult insertion¿ with a potential root cause of "catheter too stiff for insertion and rough or irregular shape protrusions".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: ¿2.Holding the labia apart with one hand (figure 3), tale the catheter and insert the tip of the catheter slowly into the urethra.".

• 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: 9316194
• Report Number: 1018233-2019-07286
• Device Sequence Number: 2408286
• Product Code: KOD
• UDI-Device Identifier: 00801741039027
• UDI-Public: (01)00801741039027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 08/31/2021
• Device Model Number: 015914
• Device Catalogue Number: 015914
• Device Lot Number: NGAV2605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1