MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D7768
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
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.Evaluation: a photo of the sample was received for analysis.Upon visual inspection of the picture it was verified a piece of paper in inner package seal.This paper caused mark indicating the inner package was caught and part of it was out of the sterilized package.An empty opened overwrap and an opened straight pack folder with four parked needle/suture combinations were returned for analysis.During the visual inspection of sample, a piece of the straight-pack folder in the overwrap seal area was observed.In addition, a section of the seal is partially open compromising the sterile barrier.Per the condition of the sample received the assignable cause of the packaging - integrity is open seal resulting in a manufacturing product defect.
Event or Problem Description
It was reported that during unknown procedure suture was used on (b)(6) 2018.The package had the inner paper package caught at the sealed area of the outer package.Part of the inner package had protruded to the outer package.When trying to open the outer package, the inner package was torn because a the inner package adhered to the sealed area of the outer package.There were no adverse consequences to the patient.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7462639
• Report Number: 2210968-2018-72345
• Device Sequence Number: 1252649
• Product Code: GAW
• UDI-Device Identifier: 10705031028357
• UDI-Public: 10705031028357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 03/01/2018

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: 01/31/2022
• Device Catalogue Number: D7768
• Device Lot Number: LBJ626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1