MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y605H
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	07/18/2019
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 mjm295 number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The primary package of the suture was found damaged prior to planned use.No additional information could be provided.The device was not used on the patient.Upon review of photo of the unopened sample, it was observed that top foil was ripped and damaged.
Additional Manufacturer Narrative
The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.It was received for analysis an unopened sample.During the visual inspection, it was observed that top foil was ripped and damaged.However, no conclusion could be reach as to may caused the reported incident.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, it could not be determined what may have caused the reported incident.A photo of an unopened sample was received for analysis.Upon visual inspection of the picture, a damaged on the top foil of the unopened sample was observed.However, no conclusion could be reach on how this happen.

• Brand Name: MCRYL VIO 27IN 2-0 S/A UR-6
• 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: 8897667
• Report Number: 2210968-2019-85623
• Device Sequence Number: 240827
• Product Code: GAN
• UDI-Device Identifier: 10705031059481
• UDI-Public: 10705031059481
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960653
• 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): 07/19/2019

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: 07/31/2023
• Device Catalogue Number: Y605H
• Device Lot Number: MJM295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1