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

Model Number	0094120
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
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 the catheters had an alleged white powder, film or residue on them and were not used.As per additional information received via email on 25aug2020 from investigator, the catheter was found to have ozone damage during evaluation.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.A potential root cause for this failure mode was unable to determine.The degradation on the catheter appears to indicate that there was a relationship between the device and the reported event.As the cause of the degradation was unknown, it could not be determined whether the device had met specifications.As the device was returned unopened, it appears that the device was not used for the treatment or diagnosis.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: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box." 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.
Event or Problem Description
It was reported that the catheters had an alleged white powder, film or residue on them and were not used.As per additional information received via email on 25aug2020 from the investigator, the catheter was found to have ozone damage during the evaluation.

• 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: 10541630
• Report Number: 1018233-2020-05948
• Device Sequence Number: 3508032
• Product Code: KOD
• UDI-Device Identifier: 00801741034015
• UDI-Public: (01)00801741034015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 11/30/2021
• Device Model Number: 0094120
• Device Catalogue Number: 0094120
• Device Lot Number: NGBS1848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1