MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 5-0 CLR; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 690G

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

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.

Event Description

It was reported that on (b)(6) 2018 while a nurse was checking inventory, one of the suture packages had a needle protruding from it which punctured the nurses finger.No medical treatment was necessary for the nurse.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: ETHILON SUTURE 18"(45CM) 5-0 CLR
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7267046
• MDR Text Key: 100148465
• Report Number: 2210968-2018-70837
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031008410
• UDI-Public: 10705031008410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 690G
• Device Lot Number: JHE967
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 02/27/2018
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1