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

Catalog Number	D7768
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	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: was there any adverse patient consequence? no.There wasn't.How was the injury treated? no information.The injury was tiny.Was there any medical or surgical intervention? no.If so, please provide details.N/a.How is the scrub nurse doing today? no problem.Was the sterility of the package compromised? no.
Event or Problem Description
It was reported that a scrub nurse assisted in a cardiovascular procedure on (b)(6) 2018 and suture was used on the patient.During the procedure, the scrub nurse pricked his/her finger on the needle when trying to take out the needle from the package.This event occurred because the needle had protruded from the package before opening the package.The injury was slight.There was no medical or surgical intervention required for the nurse and it was reported as the nurse having no current problems.There were no adverse consequences for the nurse or the patient.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
There is no sample returned for analysis.A photo of the sample was returned for evaluation.Upon visual inspection of the picture, an unopened sample with the tip of the needles outside of the package of product code d7768 with lot # lmh352 could be observed.During investigation, it was found that the folder had the needle holder foam as per procedure, although 2 needles penetrate the needle holder and the folder sale carton.The remaining six (6) needles were currently park.Based on the evaluation, event was recreated and was found that the folder flap is not flat against the needles, causing the needle holder foam not to touch the needles.If during the process handling, the needle rotated (point up), there is a low probability that the packaging operator will detect it because the needle will penetrate the folder during the placement of the material in the dispenser box.No conclusion could be reached on how an extra sample was found as the sample was not returned for analysis.

• Brand Name: PROLENE SUTURE 36"(90CM) 4-0 BLU
• 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: 7320453
• Report Number: 2210968-2018-71320
• Device Sequence Number: 109952
• 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,Followup,Followup
• Report Date (Section B): 02/20/2018

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: D7768
• Device Lot Number: LMH352
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 05/18/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 03/21/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1