MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number VR917

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> pc- (b)(4).Component code: (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 lot, and no non-conformances were identified.Event related to mw # 2210968-2022-02646, mw # 2210968-2022-02648, mw # 2210968-2022-02649.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle tip was found blunt when sewing, and the suture broke.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente; dutra, km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14103249
• MDR Text Key: 298665223
• Report Number: 2210968-2022-02647
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: 10705031134768
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2022

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
• Device Operator: Health Professional
• Device Model Number: VR917
• Device Catalogue Number: VR917
• Device Lot Number: AR2438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1