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

Catalog Number	0117080
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	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.When the investigation has been completed, a supplemental emdr will be submitted.
Event or Problem Description
As reported, it was identified that after opening the perfix light plug package on (b)(6) 2020, a foreign material like filamentous polypropylene was found on the plug.There was no reported patient injury and the patient did not have infection at the time of implant.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not yet begun.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.As reported, it was identified that after opening the package a foreign material like filamentous polypropylene was found on the plug.The subject device was returned for evaluation.Visual evaluation of the returned material confirmed to be a piece of the monofilament used when stitching the petals together.There was no alleged detachment of the plugs during use indicating that the material found is residual from the manufacturing process likely from the when the thread was cut.Based on sample evaluation and investigation performed, the reported event was confirmed and the root cause was determined to be manufacturing related.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2019.
Event or Problem Description
As reported, it was identified that after opening the perfix light plug package on (b)(6) 2020, a foreign material like filamentous polypropylene was found on the plug.There was no reported patient injury and the patient did not have infection at the time of implant.

• 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: 10753989
• Report Number: 1213643-2020-20024
• Device Sequence Number: 16428738
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 10/28/2024
• Device Catalogue Number: 0117080
• Device Lot Number: HUDX2666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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