MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 2-0 S/A CTB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB839D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure (b)(6) 2022 and suture was used.Before use on the patient, upon initial inspection of the samples, there is a parked needle, an undispensed suture, and six parked needles/sutures combination, no external damages were observed on the six samples.The product is a control release, and each packet contains eight strands.After investigation of the sample short insertion was observed in one strand (slot 8).The visual inspection concluded that the combination of the needle/suture were found detached since the insertion end of the suture did not meet the requirement.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device analysis: one opened sample of product code vcpb839d was returned for analysis.Upon initial inspection of the samples, there is a parked needle, an undispensed suture, and six parked needles/sutures combination, no external damages were observed on the six samples.The product is a control release, and each packet contains eight strands.After investigation of the sample short insertion was observed in one strand (slot 8).The visual inspection concluded that the combination of the needle/suture were found detached since the insertion end of the suture did not meet the requirement.No defects were detected on the samples (from slot 1 to slot 6).The swages and attachments area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues related no defects were observed during the evaluation.In addition, a functional test was performed for samples (from 1 to 6), and the pull force was above the minimum requirements.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through quality system.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.

• Brand Name: VCL+ UD 8X18IN 2-0 S/A CTB-1 CR
• 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
• MDR Report Key: 14288226
• Report Number: 2210968-2022-03328
• Device Sequence Number: 12083076
• Product Code: GAM
• UDI-Device Identifier: 10705031056602
• UDI-Public: 10705031056602
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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 Expiration Date: 06/30/2026
• Device Model Number: VCPB839D
• Device Catalogue Number: VCPB839D
• Device Lot Number: RHMHXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2021
• 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