MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 18IN(45CM) 5-0 WHT; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1764G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, 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, and no non-conformance's were identified.
Event or Problem Description
It was reported that there was an error in suture packaging.It was reported that the boxes were incorrectly printed, since the code had the wrong needle.The suture is supposed to have s-24 needle, however the package says s14.The issue was noticed in a warehouse.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/21/2020.Corrected information: b1, h1 ¿ additional information was received that indicated this event does not meet reporting criteria.This event therefore is not reportable.

• Brand Name: MERSILENE SUTURE 18IN(45CM) 5-0 WHT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9512201
• Report Number: 2210968-2019-91254
• Device Sequence Number: 399677
• Product Code: GAT
• UDI-Device Identifier: 10705031002463
• UDI-Public: 10705031002463
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2024
• Device Model Number: 1764G
• Device Catalogue Number: 1764G
• Device Lot Number: PGZ567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1