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

Model Number	086012
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
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 a pinhole was found on the connection between the funnel and the shaft of the catheter.
Event or Problem Description
It was reported that a pinhole was found on the connection between the funnel and the shaft of the catheter.
Additional Manufacturer Narrative
The reported event was confirmed a bardex 4-wing malecot catheter was returned.A pinhole was noted on the shaft near the funnel.A potential root cause for this failure could be "operator error".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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.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." the user guide currently contains instruction that would assist in preventing potential user related causes of reported issue." 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® MALECOT MODEL DRAIN
• Common Device Name: URETHERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9484235
• Report Number: 1018233-2019-08038
• Device Sequence Number: 2784535
• Product Code: FEW
• UDI-Device Identifier: 00801741023828
• UDI-Public: (01)00801741023828
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 11/08/2023
• Device Model Number: 086012
• Device Catalogue Number: 086012
• Device Lot Number: MCCY0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1