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

Model Number 086014

Device Problems Misassembled (1398); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that a pinhole was found on the connection between the funnel and shaft.

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 Description

It was reported that a pinhole was found on the connection between the funnel and shaft.

Event Description

It was reported that a pinhole was found on the connection between the funnel and shaft.

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.

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 Description

It was reported that a pinhole was found on the connection between the funnel and shaft.

• Brand Name: BARDEX® MALECOT MODEL DRAIN
• Type of Device: URETHERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9497547
• MDR Text Key: 179239272
• Report Number: 1018233-2019-08111
• Device Sequence Number: 1
• Product Code: FEW
• UDI-Device Identifier: 00801741023835
• UDI-Public: (01)00801741023835
• Combination Product (y/n): N
• PMA/PMN Number: K070879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1