MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J586H
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	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How was the integrity of the seal compromised? did the packaging look damaged? where there any quality issues noted prior to the packaging being handled?.
Event or Problem Description
It was reported by the distributor that when the customer received their order on (b)(6) 2017, the outer box looked fine but when opened the suture was outside of its packaging and no longer sterile.No patient involvement and no adverse patient consequences.Additional information has been requested.

• Brand Name: VICRYL SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7052305
• Report Number: 2210968-2017-71395
• Device Sequence Number: 11030164
• Product Code: GAM
• UDI-Device Identifier: 10705031041479
• UDI-Public: 10705031041479
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: J586H
• Device Lot Number: LBM829
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1