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

Catalog Number	7731G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When was this noticed? within j&j control or outside of j&j control? was the box opened to see if the product package inside had s-24 on it as well? was this discovered at the distributor or at a hospital or similar facility?.
Event or Problem Description
It was reported that prior to any procedure or to use on a patient, it was noted that the suture box said it was a certain type but should have been a different type.There were no adverse patient consequences as product was not used.Additional information has been requested.

• Brand Name: ETHILON SUTURE 18IN(45CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7086321
• Report Number: 2210968-2017-71600
• Device Sequence Number: 1799043
• Product Code: GAR
• UDI-Device Identifier: 10705031010635
• UDI-Public: 10705031010635
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 7731G
• Device Lot Number: LB6791
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1