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

Catalog Number	0117060
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a foreign material was found on the perfix light plug.The material was removed from the device and the device was implanted into the patient.The material removed was returned for evaluation.The evaluation confirmed the material to be a piece of the monofilament used when stitching the petals of the perfix light plug together.There was no alleged detachment of the plug during use, indicating that the material found is residual from the manufacturing process likely from the when the thread is cut.Based on the investigation and returned sample evaluation, the root cause is determined to be manufacturing related.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2020.
Event or Problem Description
As reported, it was identified that while opening the package on (b)(6) 2020, a foreign material like frayed thread was found on the perfix light plug.The device was used after removing the foreign material.There was no reported patient injury.

• Brand Name: PERFIX PLUG LIGHT
• 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: 10790538
• Report Number: 1213643-2020-20033
• Device Sequence Number: 11034875
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 12/28/2024
• Device Catalogue Number: 0117060
• Device Lot Number: HUEN0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/05/2020
• 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