MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD ALL PURPOSE URETHRAL CATHETER

Model Number	0094180
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the device was had loose white particles on the component along with frayed edges.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "component damaged or defective (provided by the supplier).A potential root cause for this failure could be due to " defective material mixed in the raw material lot from supplier".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 because labeling could not have prevented the reported failure.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the device was had loose white particles on the component along with frayed edges.

• Brand Name: BARD ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10355347
• Report Number: 1018233-2020-04940
• Device Sequence Number: 3220020
• Product Code: KOD
• UDI-Device Identifier: 00801741034046
• UDI-Public: (01)00801741034046
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 07/31/2022
• Device Model Number: 0094180
• Device Catalogue Number: 0094180
• Device Lot Number: NGEQ1815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1