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

Catalog Number	SXX50
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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-conformances were identified.
Event or Problem Description
It was reported that the sterile package was pierced by inside needle which has left a hole on the package.Changed another one to complete the surgery.There was no adverse patient consequences reported.
Additional 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
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8618465
• Report Number: 2210968-2019-81460
• Device Sequence Number: 284979
• Product Code: GAT
• UDI-Device Identifier: 10705031050693
• UDI-Public: 10705031050693
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 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: 05/16/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1