MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP316H
Medical Device Problem Codes	Break (1069); 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
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: an empty opened foil, a paper lid and a winding former with an un-dispensed suture of product code (b)(4), lot # lam914 were returned for analysis.During the visual inspection of the winding former, there was evidence of the needle been parked on the tray.Since, marks of the needle were observed on the slot.However, the suture could not be dispensed from the tray, since has begun with the process of degradation, this caused the missing needle.In addition, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on the top and bottom foil package due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition of the sample received suture degradation was noted due to the improper handling of package.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture did not have a needle.The device was returned for evaluation.Upon evaluation, suture degradation and holes in the package were found.No adverse patient consequences were reported.

• Brand Name: MCRYL+ VIO 27IN 3-0 S/A SH
• 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: 8215809
• Report Number: 2210968-2019-78170
• Device Sequence Number: 11176957
• Product Code: GAM
• UDI-Device Identifier: 10705031046368
• UDI-Public: 10705031046368
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050845
• 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
• Report Date (Section B): 12/07/2018

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: 12/31/2018
• Device Catalogue Number: MCP316H
• Device Lot Number: LAM914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1