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

Catalog Number	PXX50
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that suture was to be used on unknown date during unknown procedure.Prior to the procedure it was noted that one suture needle was sticking up through the package.There was no patient consequence.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4).2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.An unopened sample of product was returned for analysis.The product 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 holes were 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 holes on cavity.The manufacturing records were reviewed and the manufacturing / packaging criteria were prior to the release of this batch.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 4GRN/4WHT 30IN 2-0 DA V-5 8PLGT
• 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: 7732530
• Report Number: 2210968-2018-74736
• Device Sequence Number: 16485147
• Product Code: GAT
• UDI-Device Identifier: 10705031049321
• UDI-Public: 10705031049321
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2018

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: 08/31/2022
• Device Catalogue Number: PXX50
• Device Lot Number: LKZ585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 08/09/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/07/2018; 09/05/2018
• Patient Sequence Number: 1