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

Model Number	VCP441H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Attempts to obtain the device have been made with no response to date.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.
Event or Problem Description
It was reported a patient underwent an episiotomy on (b)(6) 2019 and suture was used.The needle pulled off suture after sewing the first stitch.Changed to another suture to complete the surgery.No reported patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional h3 device evaluation summary: it was received for analysis a detached needle and a suture piece of product code (b)(4), lot pg2246.During the visual inspection of the detached needles, the swage and attachment area were noted to be as expected.However, body fluids, no remnant at the barrel hole and marks on the needles that appears to be by the use of a surgical instrument could be observed.The suture piece was examined, and the ends were cut that appears to be by use of a surgical instrument.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples condition, it could not be determined what may have caused the reported incident of: ¿that the problem of pulling off suture needle happened after sewing the first stitch in the surgery¿.

• Brand Name: VCL+ UD 27IN 4-0 S/A FS-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: 9563735
• Report Number: 2210968-2020-00202
• Device Sequence Number: 2866284
• Product Code: GAM
• UDI-Device Identifier: 10705031053274
• UDI-Public: 10705031053274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 05/31/2024
• Device Model Number: VCP441H
• Device Catalogue Number: VCP441H
• Device Lot Number: PG2246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1