MAUDE Adverse Event Report: ETHICON INC.; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B414
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported upon opening the box of barbed suture on (b)(6) 2026.The label of the outer box shown as product code with cutting needle but inner sutures are product with rounded body.Found only 1 piece with the correct item out of whole box.No reported adverse patient consequences.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information was requested, and the following was obtained: 1.Could you please clarify if extra device belongs to this complaint? ans: yes, the product has a packaging of sxmp2b414, lot#: 108p5c, but it contains a mixture of sxmp2b414 lot#: 108p5c and sxpp2b414 (lot#: 1019ga) in same box, according to hospital feedback.2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.Ans: same product complaint.3.If the device was not reported before, please provide more details of device malfunction.Ans: na.4.If the product doesn't belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Ans: na.Additional information provided: did the event occur during sterile processing? unknown, did the event occur during field inspection? unknown, did the event occur during internal service activities such as calibration? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown.Attempts to obtain the device have been made.If 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 number, and no related non-conformance's were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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
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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection revealed that one open box with ten unopened foil packets was received for analysis.Upon initial inspection of the box received, it was found that the foil packets belong to product code sxpp2b414, lot 1019ga.While the box pertains to product code sxmp2b414 whit lot 108p5c.Due to the mismatch observed, a further analysis to determine if the complaint represents a defect/or a process deviation.Based on the findings, the foil packets labeled lot 1019ga were manufactured on may 28, 2024, with an expiry date of april 30, 2026.The box associated with lot 108p5c was produced on may 28, 2025, and expires on april 30, 2027.Given the one-year difference between the production dates, it is not possible for these items to have been mixed during the manufacturing process.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.

• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24877570
• Report Number: 2210968-2026-03955
• Device Sequence Number: 21337180
• Product Code: NEW
• UDI-Device Identifier: 10705031464612
• UDI-Public: (01)10705031464612(17)260430(10)1019GA
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K192144
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 04/30/2026
• Device Catalogue Number: SXPP2B414
• Device Lot Number: 1019GA
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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