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

Catalog Number 5955800

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.Visual evaluation noted the product carton is crushed in on the back side which resulted in a tear/hole in the carton.A visible tear was found in the inner sterile foil pouch.The tear in the foil pouch corresponds with the damage to the product carton.The damage to the product carton occurred from an outside impact going into the foil pouch resulting in a breach of the sterile barrier.The condition of the carton is not indicative of the as shipped condition and would have been discovered prior to distribution.Based on the sample evaluation and the investigation performed, the root cause is damage occurring in transit/handling after leaving the distribution center.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december, 2020.Note, the date of event provided is a best estimate based on the date of awareness of the reported event.

Event Description

As reported, when the materials manager was stocking inventory, there was damage noted to the product carton of a bard/davol ventralight st mesh w/ echo ps.As reported, the person who received the product in, states there was no damage noted to the outer shipping box during receipt, but the product carton inside the outer shipping box was noted to have a hole.There was no reported patient involvement.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: 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: 11799323
• MDR Text Key: 255839474
• Report Number: 1213643-2021-20109
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Catalogue Number: 5955800
• Device Lot Number: HUEX0976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other