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

Catalog Number	5955800
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 11799323
• Report Number: 1213643-2021-20109
• Device Sequence Number: 3972533
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• 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