MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 5"(13CM) 10-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2790G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by a sales that the patient underwent an unknown procedure on (b)(6) 2017 and suture was used.It was found that the suture had been caught at the sealed area of the package.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
The actual device involved in this event was returned for evaluation.The evaluation found that during the visual inspection of the sample of the overwrap packet it was observed suture material in the seal area; however not compromising the sterile barrier.Per the sample condition the assignable cause of the packaging integrity is a suture in the seal during manufacturing.

• Brand Name: PROLENE SUTURE 5"(13CM) 10-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7107240
• Report Number: 2210968-2017-71711
• Device Sequence Number: 1234765
• Product Code: GAW
• UDI-Device Identifier: 10705031003859
• UDI-Public: 10705031003859
• Combination Product (Y/N): N
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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 Catalogue Number: 2790G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1