MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number J214H

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: were only 2 devices of the incorrect vicryl plus vcp311 lot lpm513 sutures found in the box of vicryl suture j214h lot mam223? no, vcp311h*36ea (lot: lpm513) were in the box of j214h (lot: mam223) was the issue noted in a newly opened box? yes.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.Did 2 boxes of j214h lot mam223 contain vcp311 lot lpm513 sutures?.

Event Description

It was reported that a patient underwent unknown procedure on unknown date and suture was used.Prior to the procedure it was reported that the box contained the incorrect code and lot number of suture.There were no adverse patient consequences reported.

Manufacturer Narrative

Pc-000225543 date sent to the fda: 08/01/2018 additional information was requested and the following was obtained: 1.Did 2 boxes of j214h lot mam223 contain vcp311 lot lpm513 sutures? yes.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.An opened box of product code (b)(4), lot mam223 containing thirty-five unopened samples of a different product code (b)(4) , lot lpm513 were returned for analysis.During the visual inspection of box, a mismatched between box and the individual foils inside were observed.For this reason, a characterization of samples was conducted, and the following was observed: thirty-five foils were examined and no defects were found on the packages.The samples were opened, and the swage and attachment area of the needles were as expected.Also, the samples were examined by needle characteristic on point type, needle type and needle curvature and suture characteristic and the product contained in each packet belong to product code (b)(4), lot lpm513.In addition, the manufacturing date is on (b)(4), 2017.The box with the product code (b)(4), lot mam223 were examined and excessive manipulation could be observed.Also, the manufacturing date is on (b)(4), 2018.Also, the manufactured dates were reviewed there are a difference of a month of separation between the manufacture date of the reported lots.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to manufactured dates and that the box was received opened a mix of product could not be happened in our manufacturing sites and the assignable cause of the assembly incorrect implantable is an improper handling and the reported complaint.

• Brand Name: VICRYL SUTURE 27"(70CM) 4-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7715737
• MDR Text Key: 114937654
• Report Number: 2210968-2018-74588
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031038226
• UDI-Public: 10705031038226
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: J214H
• Device Lot Number: MAM223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1