MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B434
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and barbed suture was used.Before use on the patient, it was reported that the primary package of the suture was found damaged prior to use.Changed another one to complete the surgery.During the inspection of the returned sample, a hole was noted to be outside to in caused by an unknown object trespassing on the complete foil package.This hole is affecting the product integrity.Blue ink was also noted on the hole area.Due to the damages found on the device, the complaint is confirmed, a possible cause for these conditions is due to improper handling during transit or storage.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3 investigation summary: the product was returned for evaluation.One unopened sample was received for analysis.Product code sxmp1b434.During the inspection of the returned sample, a hole was noted to be outside to in caused by an unknown object trespassing on the complete foil package.This hole is affecting the product integrity.Blue ink was also noted on the hole area.Due to the damages found on the device, the complaint is confirmed, a possible cause for these conditions is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: was the sterility of the device compromised? - are there any tears/holes in the sterile packaging? -were there any issues with the seal of the sterile packaging? are there any photos available for visual analysis? contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.

• Brand Name: SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20000608
• Report Number: 2210968-2024-08694
• Device Sequence Number: 17381788
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: (01)10705031236530(11)231018(17)240718(10)TLBEJD
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• 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
• Report Date (Section B): 08/19/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: SXMP1B434
• Device Lot Number: TLBEJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown