MAUDE Adverse Event Report: ETHICON INC. GUT CHR BLU 18IN 6-0 D/A S-14; SUTURE, ABSORBABLE, NATURAL

Model Number	1791G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: please provide the lot number.Could you please confirm the quantity of devices that "did not have expiration dates printed in the back f the package".Event date and procedure name? lot # rgmmqk.12 eaches affected (1 box).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before used on patient, it was reported that a box of their chromic suture did not have expiration dates printed on the individual packages.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/16/2021.H6 component code: g07002 no device return.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: after visual inspection of two images received to ethicon inc for evaluation.A package is missing the printed letter.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.In the three-sample condition, the assignable cause is mislabeling.The information you provide is routinely collected, monitored, and reviewed for any associated trends.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 BLU 18IN 6-0 D/A S-14
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12848588
• Report Number: 2210968-2021-11778
• Device Sequence Number: 19970149
• Product Code: GAL
• UDI-Device Identifier: 10705031002579
• UDI-Public: 10705031002579
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 05/31/2026
• Device Model Number: 1791G
• Device Catalogue Number: 1791G
• Device Lot Number: RGMMQK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown