MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Model Number 0112670

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the bard flat mesh sterile package was damaged prior to use.The subject device was discarded by the user facility and was not available for evaluation, as such we are unable to review for root cause determination and no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use, provided with the device states, ¿this device must be sterile before use.Please inspect the packaging to be sure it is intact and undamaged.¿ should additional information be provided, a supplemental mdr will be submitted.

Event Description

As reported, on (b)(6) 2020 prior to an open procedure outside the operating room, the bard flat mesh package was noted to be damaged and there was a concern for sterility breach.There was no patient involvement.The mesh was discarded and a new mesh was used to complete the procedure.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11018375
• MDR Text Key: 223177283
• Report Number: 1213643-2020-20081
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0112670
• Device Catalogue Number: 0112670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other