MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J532H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: what tissue/ location was suturing when pull off occurred? abdomen close.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no.How much time the surgery was the prolonged due to pull off event? unknown.Lot number? unknown.Procedure date? ectopic pregnancy surgery.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 a patient underwent an ectopic pregnancy procedure on (b)(6) 2021 and suture was used.During the closure of the abdomen, the suture pulled off the needle.The surgery was completed with a new absorbable suture.The procedure was delayed for an unknown amount of time.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12925321
• Report Number: 2210968-2021-12336
• Device Sequence Number: 4906467
• Product Code: GAM
• UDI-Device Identifier: 10705031040984
• UDI-Public: 10705031040984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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 Model Number: J532H
• Device Catalogue Number: J532H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female