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

Model Number	056118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 rubber on the catheter was cracking which was noted prior to use.
Additional Manufacturer Narrative
The reported event was confirmed but the root cause is unknown.Evaluation of the photo samples suggests that there are multiple cracks along the shaft and the drainage funnel of the catheter.The photo samples are not sufficient to definitively determine the root cause of the event.A potential root cause of the reported event could be improper compounding of raw material due to which the catheter surface skinned and cracked, resulting in procedure delay, product not being usable, and replacement of device.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." 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 rubber on the catheter was cracking which was noted prior to use.

• 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: 8926358
• Report Number: 1018233-2019-05068
• Device Sequence Number: 19384726
• Product Code: KOD
• UDI-Device Identifier: 00801741033544
• UDI-Public: (01)00801741033544
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 056118
• Device Catalogue Number: 056118
• Device Lot Number: NGBS1828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1