MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 12IN 4-0 D/A M-2; SUTURE, ABSORBABLE, NATURAL

Model Number	751G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's 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.Please specify patient consequences if any for each patient? what is the name of the procedure? what is the procedure name and date? what is the event date? was the outer case that the package arrived in damaged? where did you receive the product from (ethicon, distributor, etc)? was the suture seals on the foil still intact? was the packaging torn prior to opening of the package? was any quality deficiency/non-conformance noted with each of the individual devices before use, during use, during post-op examination or during re-operation if performed? please explain in more detail "customer received, at two different times" please clarify: "surgeon noticed differences in strand as well" do you mean on the labeling identification of the strand on the box? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a customer received, at two different times, boxes of suture with different lot numbers.The description of the needle is different on the two boxes and surgeon noticed differences in strand as well.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/05/2021.Additional information: h6 additional h3 investigation summary: a photo was received.Upon visual inspection of the photo, two boxes of product code 751g, one with lot# jhk537 and the other with lot# qamjta could be observed.In addition, all data register at the box is according to the finish good requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GUT CHR UD 12IN 4-0 D/A M-2
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10639955
• Report Number: 2210968-2020-07714
• Device Sequence Number: 2555370
• Product Code: GAL
• UDI-Device Identifier: 10705031009875
• UDI-Public: 10705031009875
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 12/31/2024
• Device Model Number: 751G
• Device Catalogue Number: 751G
• Device Lot Number: QAMJTA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1