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

Model Number 086014

Device Problems Material Puncture/Hole (1504); Device Damaged Prior to Use (2284); Material Protrusion/Extrusion (2979)

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.Per additional information received via email on 4 january 2020 from the investigator, the malecot was not made nor intended to have a balloon.However, a pinhole was found on the device.Per sample evaluation, it was found that there was a protrusion coming from the malecot.

Event Description

It was reported that a pinhole was found on the connection between the funnel and shaft.Per additional information received via email on 4 january 2020 from the investigator, the malecot was not made nor intended to have a balloon.However, a pinhole was found on the device.Per sample evaluation, it was found that there was a protrusion coming from the malecot.

Manufacturer Narrative

The reported event as confirmed as manufacturing related.A bardex 4 wing malecot was returned without its original packaging.A pinhole was found on the product.Protrusions were also found on the malecot.A potential root cause for this failure could be "incorrect dial setting, equipment failure or 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.".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
• Type of Device: URETHERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9634648
• MDR Text Key: 183789807
• Report Number: 1018233-2020-00555
• 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
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1