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

Catalog Number	0117080
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the perfix light plug outer package was found to be damaged when received, which compromised the sterility of the device.As reported the subject device will be returned for evaluation but has not been received at this time.A photo has been provided and shows a portion of an open perfix plug carton with someone holding open a piece of the tyvek lid.The seal transfer on the blister tray is visible with no anomalies.The outer carton is not completely visible and outer carton damage cannot be confirmed.Photo cannot assist in determining root cause, however the most probable is transit damage as reported.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2023.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, when the customer unpacked the packaging, it was identified that the outer packaging of the perfix light plug was damaged, which destroyed the sterile environment and could not be used.It was reported that the inner packaging of the mesh plug is not sealed properly and damaged.There was no reported patient involvement.
Event or Problem Description
As reported, when the customer unpacked the packaging, it was identified that the outer packaging of the perfix light plug was damaged, which destroyed the sterile environment and could not be used.It was reported that the inner packaging of the mesh plug is not sealed properly and damaged.There was no reported patient involvement.
Additional Manufacturer Narrative
As reported, the perfix light plug outer package was found to be damaged when received, which compromised the sterility of the device.As reported the subject device will be returned for evaluation but has not been received at this time.A photo has been provided and shows a portion of an open perfix plug carton with someone holding open a piece of the tyvek lid.The seal transfer on the blister tray is visible with no anomalies.The outer carton is not completely visible and outer carton damage cannot be confirmed.Photo cannot assist in determining root cause, however the most probable is transit damage as reported.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2023.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample finds the outer carton is damaged dented/creased.The damage to the outer carton does not appear to have damaged the inner sterile blister tray, as there was no physical damage observed.The transfer seal was reviewed and is fully formed with no voids.There was no issue found with the manufacture seal finding no deformation or channels within the seal.The open package is consistent with it having been manually opened.It is not known at this time if the customer opened the tray before or after noting the transit damage.In any event the customer had concern for product sterility as reported after noting the transit damage on the outer carton.No manufacturing anomalies were found.Based on the event as reported and sample evaluation no conclusions can be made.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: 18241042
• Report Number: 1213643-2023-00467
• Device Sequence Number: 11569514
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/09/2023

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: 0117080
• Device Lot Number: HUGZ0531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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