MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D8901
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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 via: please clarify, is this product mix meaning you found in the same box 8 monocryl and also 4 vicryl of sutures before the procedure? yes, it was found in the same box during procedure before use.What is the product code and lot number for the 4 vicryl sutures found without needles? no further information is available.Provide the specific number of patient events: one.Did the event occur during one or multiple patient procedures? one.What is the total number of procedures? one.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s) no.If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).This event occurred in only one procedure.Device return status? we regularly contact with sales rep about the device returning.No further information will be provided." a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via this report and 2210968-2022-07335.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.Before use on the patient, it was reported 12 monocryl were supposed to be in the packaging, but 8 monocryl and also 4 vicryl of sutures without needles were found instead.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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 ; 9083863534
• MDR Report Key: 15369060
• Report Number: 2210968-2022-07334
• Device Sequence Number: 1829638
• Product Code: GAN
• UDI-Device Identifier: 10705031031487
• UDI-Public: 10705031031487
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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 Model Number: D8901
• Device Catalogue Number: D8901
• Device Lot Number: RMMKKJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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