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

Catalog Number	5954600
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that they inadvertently implanted an expired ventralight st and was removed.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.No patient injury was reported.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as the estimate based on the date of awareness.If/when additional information is provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
As reported, during a laparoscopic ipom (intraperitoneal onlay mesh) plus procedure, the patient underwent implant of a ventralight st 6" (15cm) mesh using a 3 mm trocar and tacked it with a non-bard (protack) device.Once the surgeon did the procedure, the nurse noticed that the mesh had expired 2 weeks ago and then the mesh was removed and another mesh was placed.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10784982
• Report Number: 1213643-2020-20030
• Device Sequence Number: 2960577
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 5954600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other