MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A PS-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y936H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.H6 component code: g07002 device not returned 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.When they opened the package, the wrong needle was on the suture.The account alleges the packages were correct but the needle attached to the suture was wrong.The procedure was completed successfully with no adverse consequences for the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/30/2024.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with twenty-four representative unopened samples and one open sample were received for analysis.Product code y936h.During the visual analysis of eighteen samples, it was observed that the printed description of the needle-sutures (needle belongs to sales type ps-1, in size 24 mils, 3/8 circle (drilled cutting edge prime reverse) and suture monocryl diameter 3-0 length 27¿ undyed color) the paper lid, did not match with the product inside of the trays.Due to this mismatch, a characterization was performed.The needles are sales type p-3, in size 13 mils, 3/8 circle, silver color, (drilled cutting edge prime reverse).The sutures belong to diameter monocryl 4-0¿, with a suture length of 18¿ undyed color.In the remainder seven samples the needle-sutures, no issues related to product mix were observed during the evaluation.Based on the information currently available, the wrong and/or mixed product was identified during the investigation of the samples received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be 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.
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.

• Brand Name: MCRYL UD 27IN 3-0 S/A PS-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19997526
• Report Number: 2210968-2024-08584
• Device Sequence Number: 15218947
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: (01)10705031059917(11)231109(17)281031(10)TMMDQD
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2024

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 Catalogue Number: Y936H
• Device Lot Number: TMMDQD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/24/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/30/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006638824-10/08/24-001-
• Patient Sequence Number: 1
• Patient Sex: Unknown