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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an open inguinal hernia repair procedure, the petal of perfix plug light mesh detached during insertion and was removed from the patient body.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusions can be made.As received the perfix plug has been handled and is contaminated from attempted use.Initial evaluation of the returned sample finds the inner petal is separated from the outer shell.Review of the returned sample is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.(b)(4).
Event or Problem Description
As reported, during an open inguinal hernia repair procedure, the petal of perfix plug light mesh detached during insertion and was removed from the patient body.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusions can be made.As received the perfix plug has been handled and is contaminated from attempted use.Initial evaluation of the returned sample finds the inner petal is separated from the outer shell.Review of the returned sample is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records shows product lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report sample evaluation details.Based on sample evaluation and manufacturing process evaluation performed, a definitive root cause could not be determined.This was not reported as an out of box event, as reported the issue presented during insertion; it is possible the event occurred due to the handling of the device in preparation for use.This event remains the only complaint to be reported to date, for this manufacturing lot of (b)(4) units released for distribution in march 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.

• 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: 16463563
• Report Number: 1213643-2023-00076
• Device Sequence Number: 2493568
• 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,Followup
• Report Date (Section B): 03/02/2023

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: HUGP1516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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