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

Catalog Number 5954680

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

The sample evaluation found that the outer carton was damaged with a visible slice which penetrated into the inner packaging. The inner foil pouch was removed and it was confirmed that a slice was visible in the foil pouch causing a breach in sterility. The slice found in the inner foil pouch corresponds to the location of the visible slice in the outer carton. The slice went clean through both sides of the foil pouch and an indentation was created in the carton underneath the foil pouch were the slice was located. The sample evaluation indicates that the damage to the packaging most likely occurred sometime after distribution, and did not occur when in bard control. It appears that the slice found in the product packaging was likely caused by a sharp object, i. E. A box cutter, with applied force during removal from a shipper box, that penetrated through the outer carton and sliced the inner foil pouch. This complaint is confirmed for breach in sterile barrier, use related. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution on (b)(6) 2017. The warning section of the instructions for use instructs the user to inspect the packaging prior to use, this action would most likely ensure that the user would be able to identify a sterility breach in the packaging prior to use on the patient, as happened in this incident. The information provided by bard 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 bard. Due to eu privacy requirements patient identifiers cannot be provided.

Event Description

It was reported that on (b)(6) 2017 while opening a bard ventralight st patch for a case it was noted that the foil pouch, housing the mesh, had a clean slice towards the top of the packaging. As reported the customer did not identify any damage to the outer packaging carton. Another ventralight st patch was used to complete the procedure and there was no injury to the patient.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6876428
• MDR Text Key: 86632367
• Report Number: 1213643-2017-00604
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5954680
• Device Lot Number: HUBP1146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial