MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 40IN 1 S/A CT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 4999G

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Evaluation: one opened box with four unopened samples of product code par570 was received for analysis.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, all packets contains a black ethilon suture with a taper point needle.No product mix or incorrect component was observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to condition of the representative samples, no assembly product mix / incorrect component was found.The reported complaint could not be observed.

Event Description

It was reported a patient underwent an unknown procedure on an unknown date and suture was used.Suture was in the wrong foil.Another suture was opened.No reported patient consequences.

• Brand Name: ETHLN BLK 40IN 1 S/A CT
• 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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 9107792
• MDR Text Key: 159745584
• Report Number: 2210968-2019-88003
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 4999G
• Device Lot Number: PAR570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 08/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1