MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 13CM M0.4::USP8/0 SGLE ARMED BV130-5; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 2808V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

A manufacturing record evaluation was performed for the finished device lot number mkz135, and no non-conformances were identified.Investigation summary: it was reported that the device had a product mix / incorrect component issue.An opened sample product code 2808, lot mkz135 was returned for analysis.During the visual inspection of the opened sample, the foam park had 9-0 printed and for product code 2808 should be 8-0 printed.Due to mismatch at the foam park a characterization of the suture was performed and meet the requirements for an ethilon suture diameter 8-0.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the assignable cause of the mix foam park is due to manufacturing defect.

Event Description

It was reported that a patient underwent a hand procedure on (b)(6) 2019 and suture was used.The suture was found inside the winder to have been 9-0 threads instead of the 8-0 threads.There were no adverse patient consequences reported.

• Brand Name: ETHILON BLK 13CM M0.4::USP8/0 SGLE ARMED BV130-5
• 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: 8957340
• MDR Text Key: 156343072
• Report Number: 2210968-2019-86499
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 2808V
• Device Lot Number: MKZ135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1