MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 4-36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D5988
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	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a lower extremity bypass surgery on (b)(6) 2017 and the suture was used.When the package was taken out from the box, it was found that the needle had protruded from the package.There were no adverse patient consequences reported.No further information is available.

• Brand Name: PROLENE SUTURE 4-36"(90CM) 4-0 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: 7076471
• Report Number: 2210968-2017-71545
• Device Sequence Number: 1108820
• Product Code: GAW
• UDI-Device Identifier: 10705031025882
• UDI-Public: 10705031025882
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 02/28/2022
• Device Catalogue Number: D5988
• Device Lot Number: LCH042
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1