MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	10X82
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).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.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 lb6409 number, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.Prior to the procedure, the needle was found protruding from the package prior to opening.The device was not used on the patient.There were.No one got injured since it was noticed in advance.No adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional evaluation summary: an unopened sample of product code 10x82, lot lb6409 was returned for analysis.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 of packaging integrity, suggest an incorrect needle park resulting in pinhole on package.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A SH
• 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: 8584757
• Report Number: 2210968-2019-81091
• Device Sequence Number: 13917706
• Product Code: GAT
• UDI-Device Identifier: 10705031001329
• UDI-Public: 10705031001329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 10X82
• Device Lot Number: LB6409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1