MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J741D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: an empty opened foil, two detached needles, six parked needle/ suture and several suture pieces of product were returned for analysis.During the visual inspection of sample, the swage and attachment area of the eight needles were as expected.The sutures could not be dispensed since; it has begun with the process of degradation and the time of exposure of suture to the environment could not be determined.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on the top and bottom foil package (from outside to inside) 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 condition of the sample received, the assignable cause of suture breakage pre-op is a suture degradation; which is a result of improper handling of package.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn procedure on an unknown date and a suture was used.During surgery, it was found that the suture had been broken into pieces when opening the package.Upon evaluation of the returned sample it was found that multiples wrinkles and holes were in cavity of foil package.The suture had begun the degradation process.There were no adverse patient consequences reported.

• Brand Name: VICRYL SUTURE 18"(45CM) 1 VIO
• 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: 8394912
• Report Number: 2210968-2019-79305
• Device Sequence Number: 389439
• Product Code: GAM
• UDI-Device Identifier: 10705031042650
• UDI-Public: 10705031042650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 02/05/2019

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: 06/30/2023
• Device Catalogue Number: J741D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1