MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP977H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #:(b)(4).(b)(4).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 pdz980 batch number, and no non-conformances were identified.This medwatch report is in response to receipt of maude event report mw 5090083.
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2019 and suture was used.The suture needle tip broke off during the procedure.It is unknown how the case was completed.The patient underwent an unknown surgical intervention.No additional information can be obtained.

• Brand Name: VCL+ UD 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9323895
• Report Number: 2210968-2019-89927
• Device Sequence Number: 1872946
• Product Code: GAM
• UDI-Device Identifier: 10705031056251
• UDI-Public: 10705031056251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: VCP977H
• Device Lot Number: PDZ980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention