MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J207G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Is the needle the correct needle just the incorrect size? or is the needle a totally different needle (a different product)? please clarify.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, it was noted that the device was a different size than what was on the package.There were no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 evaluation: an opened sample of product code j207, lot mk6373 were returned for analysis.During the visual inspection of the opened sample, it was noted that the spool had two holes punched and for this product, there should be only one hole punched.Due to mismatch at the spool a characterization of the suture was performed and meet the requirements for a product type and suture diameter.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the assignable cause of the mix reel is due a manufacturing defect.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/30/2019.Additional information was requested and the following was obtained: is the needle the correct needle just the incorrect size? or is the needle a totally different needle (a different product)? please clarify.Just different size compared to what is indicated on packaging.

• Brand Name: VCL CT BRD VIO 54IN 0 NON NDL
• 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: 8731152
• Report Number: 2210968-2019-83245
• Device Sequence Number: 2637365
• Product Code: GAM
• UDI-Device Identifier: 10705031038158
• UDI-Public: 10705031038158
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2019

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: 08/31/2023
• Device Catalogue Number: J207G
• Device Lot Number: MK6373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 08/22/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/24/2019; 08/30/2019
• Patient Sequence Number: 1