MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK 8-0 13 BV130-5; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W2808

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device mhk599 number, and no non-conformances were identified.Investigation summary: an opened sample of product code w2808, lot # mhk599 was returned for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected, further analysis showed that stringy epoxy was present on the needle cut-off area, as a result the suture needle diameter appeared to be wider.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection of the sample, the assignable cause of the needle diameter issue is a stringy epoxy.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.It was found that there was a thicker coating that made the needle diameter wider.There were no adverse patient consequences reported.Upon evaluation of the device, epoxy was present on the needle cut off area.

• 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: 8880786
• MDR Text Key: 153890434
• Report Number: 2210968-2019-85371
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: W2808
• Device Lot Number: MHK599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1