MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 1 S/A CP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP480H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device vcp480h, pcbcjps0, number, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Are devices available and being returned for evaluation? any patient consequences due to this issue and how was it managed? it is reported that 'we have 'another' incident of broken tip needle'; were all events reported? if yes, please provide pc number(s).
Event or Problem Description
It was reported that a patient underwent an emergency caesarean section procedure on an unknown date and suture was used.The surgeon noticed the broken needle tip on midway of closing the first layer of the uterus.The tip was not able to be found.An x-ray was done but the tip was not visible.There was no adverse patient consequence reported.Additional information has been requested.

• Brand Name: VCL+ VIO 27IN 1 S/A CP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8898693
• Report Number: 2210968-2019-85638
• Device Sequence Number: 13829158
• Product Code: GAM
• UDI-Device Identifier: 10705031053595
• UDI-Public: 10705031053595
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 07/19/2019

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: 02/28/2022
• Device Catalogue Number: VCP480H
• Device Lot Number: PCBCJPS0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Patient Sequence Number: 1