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

Model Number	0094140
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 catheters from the last two batches were not stiff enough.The holes on the tip were on opposite sides, which caused the catheter to bend over when trying to insert.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿packaging pattern not followed.¿ the device was not used for the treatment, though it was unknown whether the device related to the reported event or met specifications.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The labeling review was not performed due to the labelling could not have prevented the reported failure.Corrections: h3.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 from the last two batches were not stiff enough.The holes on the tip were on opposite sides, which caused the catheter to bend over when trying to insert.

• 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: 10417404
• Report Number: 1018233-2020-05263
• Device Sequence Number: 16830217
• Product Code: KOD
• UDI-Device Identifier: 00801741034022
• UDI-Public: (01)00801741034022
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/04/2020

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: Lay User/Patient
• Device Model Number: 0094140
• Device Catalogue Number: 0094140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1