MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 DA V-5 8PLDGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number SXX50

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.

Event Description

It was reported that on (b)(6) 2019 the sterile package was pierced by inside needle which has a hole left on the package.Changed another one to complete the surgery.There was no adverse patient consequences.

Manufacturer Narrative

Product complaint #: (b)(4).Additional evaluation summary: an unopened sample of product code sxx50, lot lg6957 was returned for analysis.The product code sxx50 is multi-strand and contains eight strands double armed per packet.During the visual inspection of the sample, the sterile barrier was compromised due to pin hole was observed on the copolymer and top of msda folder.The sample folder was opened, it was noted that the needle was orientated vertically in the package and this caused the hole on cavity.Based on the samples condition, the assignable cause suggest an incorrect needle park resulting in pinhole on package.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 DA V-5 8PLDGT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8618456
• MDR Text Key: 145392766
• Report Number: 2210968-2019-81459
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 10705031050693
• UDI-Public: 10705031050693
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: SXX50
• Device Lot Number: LG6957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Date Manufacturer Received: 04/24/2019
• Patient Sequence Number: 1