MAUDE Adverse Event Report: ETHICON INC. GUT PLAIN SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, NATURAL

Catalog Number	53T
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).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.Lot # ? do you have any pictures of package or box? is there an indication of how the product was distributed? is there any indication of the source? was another type of scanner used, to attempt reading the labels? what type of bar code is being scanned? do you think there were any changes /updates to packaging/design etc?.
Event or Problem Description
It was reported that prior to a procedure, a discrepancy between the inside package and the suture box was noticed.No patient involvement occurred.Additional information has been requested.

• Brand Name: GUT PLAIN SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7266732
• Report Number: 2210968-2018-70835
• Device Sequence Number: 2103873
• Product Code: GAL
• UDI-Device Identifier: 10705031006140
• UDI-Public: 10705031006140
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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 Catalogue Number: 53T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1