MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number D9185

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.It was found that the needle had protruded from the package before opening the package.Further details are not provided.There were no adverse consequences to the patient.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 GRN
• 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8413839
• MDR Text Key: 138701185
• Report Number: 2210968-2019-79410
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 10705031032316
• UDI-Public: 10705031032316
• 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
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: D9185
• Device Lot Number: MJ5093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1