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

Model Number	056112
Medical Device Problem Code	Degraded (1153)
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.The device was not returned.
Event or Problem Description
It was reported that the robinson catheter appeared dated/dry in the packaging.The packaging was reportedly "opened and caught by st that it appeared outdated." the expiration date on the catheter was 31mar2023.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to an "operator error" during the drying process.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the robinson catheter appeared dated/dry in the packaging.The packaging was reportedly "opened and caught by st that it appeared outdated." the expiration date on the catheter was 31mar2023.

• 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: 9559856
• Report Number: 1018233-2020-00166
• Device Sequence Number: 11603930
• Product Code: KOD
• UDI-Device Identifier: 00801741033513
• UDI-Public: (01)00801741033513
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 03/31/2023
• Device Model Number: 056112
• Device Catalogue Number: 056112
• Device Lot Number: NGCT2560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1