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

Catalog Number 4999G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number mlj994, and no non-conformances related to the reported complaint condition were identified.

Event Description

It was reported that a patient underwent an acl reconstruction procedure on (b)(6) 2019 and suture was used.The foil packet was opened and suture and needle inside did not match packaging (appears to be ethibond excel suture and not ethilon suture.Needle is cutting and taper point).There was no adverse patient consequence reported.

Manufacturer Narrative

Date sent to the fda: 09/11/2019.Additional h-3 summary: an opened sample was returned for analysis.During visual inspection of the sample, an undispensed green suture (braided) with a cutting-edge needle could be observed into a paper folder and foil; however, this mismatched with the print description on the foil for product code 4999 that required an ethilon black suture (monofilament) and a taper point needle.

• 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
• MDR Report Key: 8898484
• MDR Text Key: 154479360
• Report Number: 2210968-2019-85637
• 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
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 4999G
• Device Lot Number: MLJ994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 09/11/2019
• Patient Sequence Number: 1