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

Catalog Number	0117070
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a hair was found in the perfix light plug package.There was no patient injury.
Additional Manufacturer Narrative
As reported, a hair was found in the perfix light plug package.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.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 from this manufacturing lot of (b)(4) units.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.
Additional Manufacturer Narrative
As reported, a hair was found in the perfix light plug package.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.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 from this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Sample evaluation finds a foreign material (hair) present in the cone of the product blister tray.Based on the sample evaluation conducted, the root cause was confirmed to be manufacturing-related.Awareness notification was provided to all the packaging personnel in the plugs area on event reported, with emphasis on gowning requirements as outlined in the current procedural requirements.Updated fields: b4, g3, g6, h2, h3, h6, h10.Corrected field: h4.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, a hair was found in the perfix light plug package.There was no 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: 23556411
• Report Number: 1213643-2025-01099
• Device Sequence Number: 18672713
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)290928(10)HUJW1538
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Catalogue Number: 0117070
• Device Lot Number: HUJW1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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: Unknown