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

Model Number	0112670
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11018375
• Report Number: 1213643-2020-20081
• Device Sequence Number: 17042536
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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 Model Number: 0112670
• Device Catalogue Number: 0112670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other