MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX URETHRAL CATHETER ROBINSON MODEL; ROBINSON CATHETER

Model Number	056122
Medical Device Problem Code	Naturally Worn (2988)
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 red rubber catheter was getting brittle or dry before expiration.
Event or Problem Description
It was reported that the red rubber catheter was getting brittle or dry before expiration.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A photo sample of a red rubber catheter in its original packaging was returned.The catheter had white marks indicative of catheter degradation.Due to additional information from moncks quality engineering , the found degradation appears to be post-manufacturing.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: "visually inspect the product for any imperfections or surface deterioration prior to use.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.

• Brand Name: BARDEX URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: ROBINSON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10288701
• Report Number: 1018233-2020-04607
• Device Sequence Number: 2212538
• Product Code: KOD
• UDI-Device Identifier: 00801741033568
• UDI-Public: (01)00801741033568
• 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: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 056122
• Device Catalogue Number: 056122
• Device Lot Number: NGCN2122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1