MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SEPRAMESH IP; SURGICAL MESH

Catalog Number	5959480
Medical Device Problem Code	Expiration Date Error (2528)
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, a sepramesh ip that had expired was inadvertently implanted into the patient.There was no adverse outcome associated with the patient reported.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error, with no malfunction of the device.Review of the manufacturing records shows the product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december 2021.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 : not returned - remains implanted.
Event or Problem Description
As reported, during parastomal hernia repair on (b)(6) 2023, an expired sepramesh ip mesh was inadvertently implanted into the patient.The labeled expiration date of the implant is (b)(6) 2023.
Additional Manufacturer Narrative
As reported, a sepramesh ip that had expired was inadvertently implanted into the patient.There was no adverse outcome associated with the patient reported.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error, with no malfunction of the device.Review of the manufacturing records shows the product was manufactured to specification.Addendum: h11: this supplemental mdr is submitted to correct the lot quantity in manufacturer narrative.To date this is the only reported complaint for this manufacturing lot of 127 units released for distribution in december 2021.Updated fields: b4, g3, g6, h2, h11.Corrected field: h10 (manufacturer narrative - lot quantity).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 : not returned - remains implanted.
Event or Problem Description
As reported, during parastomal hernia repair on (b)(6) 2023, an expired sepramesh ip mesh was inadvertently implanted into the patient.The labeled expiration date of the implant is 28-oct-2023.

• Brand Name: SEPRAMESH IP
• 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: 18220583
• Report Number: 1213643-2023-00461
• Device Sequence Number: 5602237
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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 Expiration Date: 10/28/2023
• Device Catalogue Number: 5959480
• Device Lot Number: HUFY0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: Unknown