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

Catalog Number	5950009
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, a ventralex st mesh which had a labeled expiration date of 28-mar-2024 was implanted on (b)(6) 2024 in the patient.There was no patient injury.
Additional Manufacturer Narrative
As reported, an expired ventralex st mesh was inadvertently implanted beyond its labeled expiration date.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This event is confirmed as a use related error, with no malfunction of the device.To date, this is the only reported complaint for this manufacturing lot.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, an expired ventralex st mesh was inadvertently implanted beyond its labeled expiration date.The expiration date is included on the labeling of this product and is located on multiple levels of the packaging.This event is confirmed as a use related error, with no malfunction of the device.To date, this is the only reported complaint for this manufacturing lot.Addendum: h11: this supplemental mdr is submitted to document the additional information provided.Based on the additional information provided, it was identified that the expired mesh was opened during the preparations, but due to patient complications they could not proceed with placing the mesh, the mesh was not implanted.As such, there was no issue identified based on the reported event.Updated fields: b4, b5, e1, g3, g6, h2, h6, h10, h11.Corrected field: d.6a (implant date), g2.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, during an unknown procedure, a ventralex st mesh which had a labeled expiration date of 28-mar-2024 was implanted on (b)(6) 2024 in the patient.There was no patient injury.Addendum: it was reported that the mesh was booked for a case and was opened during the preparations, but due to patient complications they could not proceed with placing the mesh, the expired mesh was not implanted.

• Brand Name: VENTRALEX ST
• 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: 20677472
• Report Number: 1213643-2024-00544
• Device Sequence Number: 8499831
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)240328(10)HUGR1228
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/26/2024

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: 03/28/2024
• Device Catalogue Number: 5950009
• Device Lot Number: HUGR1228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 35 YR
• Patient Sex: Female