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

Model Number	086014
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 shaft.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: g4- the initial doa submitted on the 3500a form was entered incorrectly, therefore this correction is to reflect the correct doa 11/25/2019 for the initial.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 a pinhole was found on the connection between the funnel and shaft.
Event or Problem Description
It was reported that a pinhole was found on the connection between the funnel and shaft.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.A pinhole was found on the product.The root cause for this failure is an equipment failure or an operator error in the form washing (post stripping) in the automatic washer.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." 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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: g4- additional information received confirmed the date of awareness should have been 25-nov-2019 instead of 26-nov-2019 as originally reported.There was no impact to regulatory requirements since the initial mdr was still reported within 30 day timeframe.This correction is to reflect the correct mdr date of awareness as in supplemental emdr #1, the incorrect year was selected.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 a pinhole was found on the connection between the funnel and shaft.

• 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: 9497547
• Report Number: 1018233-2019-08111
• Device Sequence Number: 16979609
• Product Code: FEW
• UDI-Device Identifier: 00801741023835
• UDI-Public: (01)00801741023835
• 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,Followup,Followup
• Report Date (Section B): 02/10/2020

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: 11/26/2023
• Device Model Number: 086014
• Device Catalogue Number: 086014
• Device Lot Number: MCCY3272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/07/2020; 02/07/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/08/2020; 01/08/2020; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1