MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z452G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
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.
Event or Problem Description
It was reported a patient underwent and unknown procedure on an unknown date and suture was used.Suture packages product code inside of box do not match product code on box.Suture packet labeled as z332h (pds ii suture) and outside of box is product code z452g (pds ii suture).Customer did open one package before noticing the error.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/02/2019.Investigation summary: it was reported packaging labeling identification.An opened box of product code z452, lot # mgm577 with fourteen unopened samples of product code z332, lot # jgk489 and an unopened sample of product code z452, lot mgm577 were returned for analysis.This box requires twelve samples per box.During the visual inspection of sample, a mismatched between box (z452, lot # mgm577) and fourteen foils (code z332, lot # jgk489) were observed.However, the manufactured dates were reviewed and there is a difference of three years of separation between the manufacture date of the lot # jgk489 (date of mfg 6/23/2015) and lot # mgm577 (date of mfg 6/6/2018).The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to manufactured dates there are a difference in the years of the manufacture of the lots of product and that the box was received opened, the reported complaint of " suture inside of box is labeled z332h and outside of box says z452g." it could not be happened in our manufacturing sites and the reported complaint was due to external cause.The device history records were reviewed for lot mgm577 and the manufacturing criteria was met prior to the release of this lot.Product code z452g, expiration date: 05/31/2023, date of mfg.: 06/06/2018.The device history records were reviewed for lot jgk489 and the manufacturing criteria was met prior to the release of this lot.Product code z332h, expiration date: 05/31/2020, date of mfg.: 06/23/2015.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8112194
• Report Number: 2210968-2018-77381
• Device Sequence Number: 16709555
• Product Code: NEW
• UDI-Device Identifier: 10705031218703
• UDI-Public: 10705031218703
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 05/31/2023
• Device Catalogue Number: Z452G
• Device Lot Number: MGM577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1