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

Catalog Number	0117080
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time no conclusion can be made.As reported the sample is available for return, however at this time has not been received.Without a sample to evaluate, we are unable to review the product in question for the alleged particle inside of the product packaging.To date this is the only reported complaint for this manufacturing lot released for distribution in 01/2019.Should the sample be received, a supplemental emdr will be submitted to document the results of the sample evaluation.Not returned.
Event or Problem Description
It was reported that a piece of small particle was allegedly seen in sterile packaging of a bard/davol perfix light plug.The product was not opened or used.
Additional Manufacturer Narrative
At this time no conclusion can be made.As reported the sample is available for return, however at this time has not been received.Without a sample to evaluate, we are unable to review the product in question for the alleged particle inside of the product packaging.To date this is the only reported complaint for this manufacturing lot released for distribution in 01/2019.Should the sample be received, a supplemental emdr will be submitted to document the results of the sample evaluation.This is an addendum to the initial emdr to document the receipt and evaluation of the sample.The sample was returned unopened.Through visual evaluation a small fiber was identified in the sealed blister tray.As the blister tray was returned sealed this would suggest that the fiber was present during the inner packaging and sealing process and was not detected during visual inspections performed.This complaint is confirmed for having a manufacturing related root cause.To date this is the only reported complaint for this production lot of 271 units released for distribution in january, 2019.
Event or Problem Description
It was reported that a piece of small particle was allegedly seen in sterile packaging of a bard/davol perfix light plug.The product was not opened or used.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8663217
• Report Number: 1213643-2019-04545
• Device Sequence Number: 284749
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 12/28/2023
• Device Catalogue Number: 0117080
• Device Lot Number: HUCZ0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1