MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X27IN 0 S/A CTB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D8582
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that the patient underwent a caesarean section procedure on (b)(6) 2019 and suture was used.The suture was detached from the needle easily during interrupted suturing on the uterus.It was a control release needle.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/03/2020.A manufacturing record evaluation was performed for the finished device lot phm997, and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 8X27IN 0 S/A CTB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9577890
• Report Number: 2210968-2020-00268
• Device Sequence Number: 14187042
• Product Code: GAM
• UDI-Device Identifier: 10705031030596
• UDI-Public: 10705031030596
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 12/16/2019

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: 06/30/2024
• Device Model Number: D8582
• Device Catalogue Number: D8582
• Device Lot Number: PHM997
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1