MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J495G
Medical Device Problem Code	Material Separation (1562)
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).H6 component code: g07002 - device not returned.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.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: it was reported that "dr.Has had a problem with the j495 5-0 suture that she uses for some of her procedures.The needle has popped off a number of times." please confirm the number of procedures affected by this issue.4-5 different procedures.If possible, please confirm the number of "pop-offs" per procedure.1-3 can you identify the lot number of the products that were used? slmsjz, rpmdll when did the needle detach/pull off from the suture (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify during procedure, while running the suture.Are the devices or samples from the same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) yes, (b)(6) please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6), practice director, practice director.Possible lots: slmsjz, rpmdll.Events reported via: mwr-05032024-0001587303, mwr-05032024-0001587304, mwr-05032024-0001587305.
Event or Problem Description
It was reported that a patient underwent an unknown surgery in 2024 and suture was used.During the procedure, the customer reported that dr.Harrington has had a problem with the j495 5-0 suture that she uses for some of her procedures.The needle has popped off a number of times.They have tried different lot numbers with no fix.They pulled out one each of the j495, a 4-0 j496 and a 6-0 j492 and tested them by pulling on the suture until needle pop off.There was a significant ease of pop off with this 5-0 than the other two sutures.No adverse patient consequences were reported.Additional information was requested.
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.The following are reported possible batch numbers associated with this event: lot slmsjz : expiration date: sep/30/2027 date of mfg.: oct/28/2022.Lot rpmdll : expiration date: nov/30/2026 date of mfg.: dec/8/2021.A review of the manufacturing record evaluation for the possible batch number was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A PS-2 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: 18841020
• Report Number: 2210968-2024-02446
• Device Sequence Number: 7214556
• Product Code: GAM
• UDI-Device Identifier: 10705031040557
• UDI-Public: 10705031040557
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: J495G
• Device Lot Number: SLMSJZ, RPMDLL
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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