MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 36"(90CM) 1 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB947
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).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.
Event or Problem Description
It was reported by the distributor that product code jb947, printed on the outside of the box, doesn't relate to the lot number printed on the box.The device was not used on the patient.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # = > pc-000191689 date sent to the fda: 07/10/2018 the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: a sealed box with unopened samples of product were returned for analysis.During the visual inspection of sample, the front label of the box is present with the product code and matches.However, the mfg (manufacturing) barcode present is correct for this product.It is a special code, since; it was created when the system had a 5-digit limit and according to requirement.According the sample condition, no packaging labeling identification was observed.Since, the graphics on the box were according ethicon requirement.

• Brand Name: VICRYL SUTURE 36"(90CM) 1 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7580217
• Report Number: 2210968-2018-73363
• Device Sequence Number: 2012426
• Product Code: GAM
• UDI-Device Identifier: 10705031044081
• UDI-Public: 10705031044081
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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 Expiration Date: 01/31/2023
• Device Catalogue Number: JB947
• Device Lot Number: MBZ395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1