MAUDE Adverse Event Report: ETHICON INC. ETHILON SUT 18IN(45CM) 7-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1696G

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 a patient underwent an unknown plastic surgery on (b)(6) 2018 and suture was used.During the procedure, it was found that the suture had been protruded from the package when opening the package.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Device evaluation summary: an unopened sample of product code (b)(4), lot # maz874 was returned for analysis.During the visual inspection of the unopened sample, suture material in the seal area was noted in the packet of overwrap compromising the sterile barrier.Per the sample condition the assignable cause of the packaging integrity is a suture in the seal.

• Brand Name: ETHILON SUT 18IN(45CM) 7-0 BLK
• 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.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7711425
• MDR Text Key: 114803441
• Report Number: 2210968-2018-74561
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031002159
• UDI-Public: 10705031002159
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 1696G
• Device Lot Number: MAZ874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1