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

Catalog Number	0117060
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during fixation two petals separated from the perfix light plug, the issue was not reported as an out-of-box event.Inspection of the returned sample finds the perfix light plug has evidence of handling and is contaminated from attempted use.The sample was found to be inverted and there are two petals torn from one of the inner plugs.There is some fraying along the edge of one of the loose petals returned.Based on the reported event and condition of the sample as received the separation of the petals most likely occurred inadvertently due to user/device interface while suturing and forces applied during placement of the plug.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in december 2022.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.H3 other text: sample evaluated.
Event or Problem Description
As reported, the surgeon tried to fix the perfix light plug by ligating it with a thread and two petals detached (tore off).As reported the surgeon had pulled the thread but not the plug itself.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: 17393031
• Report Number: 1213643-2023-00269
• Device Sequence Number: 12964570
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 0117060
• Device Lot Number: HUGX0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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