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

Model Number	63614
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/13/2020
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 16 french catheters were present inside 14 french catheters box.The user noted that the products were mislabeled.Per follow up information received on 21oct2020, the box and the individual packaging for the catheters stated 14 fr, but the diameter of the catheter was much bigger than 14 fr as the customer was unable to insert some due to the larger diameter.
Additional Manufacturer Narrative
The reported event was confirmed, as a manufacturing-related.Visual inspection noted 11 unopened personal intermittent catheters were received.Visual evaluation noted no obvious defects were observed.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to viscometer failure.The product was not used for diagnosis or treatment.The product had failed to meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.Correction: a, e the actual/suspected device was inspected.
Event or Problem Description
It was reported that the 16 fr catheters were present in the 14 fr catheter box.The user noted that the products were mislabeled.Per follow-up information received on 21oct2020, the box and the individual package for the catheters stated 14 fr, but the diameter of the catheter was much bigger than 14 fr as the customer was unable to insert due to the larger diameter.

• Brand Name: PERSONAL CATHETER INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10822433
• Report Number: 1018233-2020-20875
• Device Sequence Number: 17093767
• Product Code: KOD
• UDI-Device Identifier: 00801741069291
• UDI-Public: (01)00801741069291
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 10/28/2024
• Device Model Number: 63614
• Device Catalogue Number: 63614
• Device Lot Number: JUDY0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other