MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y489G
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	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device jjk598 batch number, and no non-conformances were identified.Summary: it was received for analysis an empty opened foil, a paper lid and a winding former with a stuck detached needle and a suture in several pieces of product code y489, lot jjk598.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected and remnant of suture was observed inside barrel hole.The winding former was visually examined, and the suture could not be dispensed since has begun with the process of degradation and this condition caused that the suture was detached of the needle.The time of exposure of sutures to the environment could not be determined.Also, the foil was examined and showed multiples wrinkles and holes in cavity on bottom foil packet due to excessive manipulation.Per the condition of the samples, the assignable cause of performance detached needle, is suture degradation; due to the improper handling of package.
Event or Problem Description
It was reported that the patient underwent a dental and oral surgery on (b)(6) 2019 and the suture was used.During the evaluation, the packaging foil showed holes in cavity on the bottom.There were no patient consequences reported.

• Brand Name: MCRYL UD 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9335838
• Report Number: 2210968-2019-90036
• Device Sequence Number: 19314639
• Product Code: GAN
• UDI-Device Identifier: 10705031059276
• UDI-Public: 10705031059276
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964072
• 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): 10/29/2019

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: 07/31/2020
• Device Catalogue Number: Y489G
• Device Lot Number: JJK598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/18/2019
• Patient Sequence Number: 1