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

Catalog Number	0117070
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after opening the package of a bard/davol perfix light plug on (b)(6) 2021, the mesh was noted to be frayed.The mesh was not used on the patient.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, perfix light plug was found to be frayed upon opening the package.The subject device was returned for evaluation.Initial evaluation finds the sample to be unused with no evidence of excessive handling or manipulation with no visible contamination found.Visual evaluation finds that one of the monofilament threads of the mesh structure may have become untied / loosened resulting in what looks like frayed material.The sample evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of 525 units released for distribution in june, 2021.
Additional Manufacturer Narrative
As reported, perfix light plug was found to be frayed upon opening the package.The subject device was returned for evaluation.Initial evaluation finds the sample to be unused with no evidence of excessive handling or manipulation with no visible contamination found.Visual evaluation finds that one of the monofilament threads of the mesh structure may have become untied / loosened resulting in what looks like frayed material.The sample evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2021.Addendum: this is an addendum to the initial mdr submitted to document the results of device evaluation.The sample evaluation identified a loose monofilament on the returned sample.Based on the investigation performed and sample evaluation, the root cause is determined to be manufacturing related.Awareness training was provided to all manufacturing personnel.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, after opening the package of a bard/davol perfix light plug on (b)(6) 2021, the mesh was noted to be frayed.The mesh was not used on the patient.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
• 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: 13124782
• Report Number: 1213643-2021-20484
• Device Sequence Number: 19959700
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• 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: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

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: 04/28/2026
• Device Catalogue Number: 0117070
• Device Lot Number: HUFS0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male