MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5991520
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair on (b)(6) 2023, the surgeon needed a larger sized mesh during the case and when the or nurse realized the ventralight st w/ echo 2 had an expiration date of 28-may-2023, informed the surgeon; however, the surgeon wanted to use the mesh anyways and implanted the mesh.It was reported that there was no damage to the sterile packaging and there was no additional medical or surgical intervention.
Additional Manufacturer Narrative
As reported, an expired ventralight st mesh was implanted using echo 2 ps into the patient.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.To date, this is the only reported complaint for this manufacturing lot.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.H3 other text : not returned - remains implanted.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 17293363
• Report Number: 1213643-2023-00256
• Device Sequence Number: 4109522
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 05/28/2023
• Device Catalogue Number: 5991520
• Device Lot Number: HUGT1518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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