MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 36"(90CM) 0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J958H
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	01/01/2018
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.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.
Event or Problem Description
It was reported that on an unknown date, that the distributor received a box of suture and the box was crushed.The distributor stated that the packages inside the box (primary packaging) were damaged and could possible affect sterility.There was no patient involvement and no adverse patient consequences.No additional information has been provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary: a sealed box of product code j958, lot mb2685 was returned for analysis.During the visual inspection of the box, no damaged on the film was noted; but, one side of the box was slight crushed and wrinkled.However, the integrity of product was not compromised.In addition, cannot be determined the condition of the storage, transportation and handling of the sample due to the sample condition it could not be determined what may have caused the reported incident of: ¿the box was crushed¿.

• Brand Name: VICRYL SUTURE 36"(90CM) 0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7597416
• Report Number: 2210968-2018-73444
• Device Sequence Number: 11311135
• Product Code: GAM
• UDI-Device Identifier: 10705031043725
• UDI-Public: 10705031043725
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 01/31/2023
• Device Catalogue Number: J958H
• Device Lot Number: MB2685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1