MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP218H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.A manufacturing record evaluation was performed for the finished device lot number mk2999 / vcp218h, and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: how many sutures needles were separated during suturing on this one patient during this single surgical procedure? one was the needle removed from the patient during the same procedure? yes what tissue/location was suturing when pull off occurred? the uterus were there any unexpected outcomes or complications as a result of this suture needle pull off event? a minor delay in case, while finding the suture and removing it.Was the patient treatment altered in anyway due to the prolonged surgery time? no procedure name and date? c-section the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that an empty opened foil, an empty labeled winding former a used needle, and a suture piece of product code vcp218h were received for evaluation; in the used needle the swage and attachment area were as expected, and the remnant of the suture was noted into the barrel hole and marks were observed on the body and the edge of the needle that appears to be by the use of a surgical instrument.In addition, the ends of the suture were cut appears to be by use of the surgical instrument.The condition of the sample received indicates improper handling of the device.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Investigation summary: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned devices.Visual analysis of the returned samples determined that seven unopened samples of product code vcp218h were received for evaluation.Visual inspection of the unopened samples and no defects were found on the package.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage or splitting were observed.A functional test was performed and the pull force was above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.(b)(6).Note: events reported via mw# 2210968-2021-01596.
Event or Problem Description
It was reported that the patient underwent c-section on an unknown date and suture was used.During the procedure, when the doctor was closing the uterus with the suture, the needle popped off the suture.The procedure was completed successfully with a four minute delay.There were no adverse consequences for the patient.

• Brand Name: VCL+ UD 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11350059
• Report Number: 2210968-2021-01597
• Device Sequence Number: 728449
• Product Code: GAM
• UDI-Device Identifier: 10705031051706
• UDI-Public: 10705031051706
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 08/31/2023
• Device Model Number: VCP218H
• Device Catalogue Number: VCP218H
• Device Lot Number: MK2999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1