MAUDE Adverse Event Report: CAREFUSION INC. CLOSED-END KNOT PUSHER

Model Number 89-6300

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The user facility reported during a patient procedure that their knot pusher had a "burr" inside causing the suture wire to snag and rip.It has been reported that the patient had to be re-sutured.No report of injury or procedure delay.

Manufacturer Narrative

V.Mueller has requested the device subject of the reported event be returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

The device subject of the event was returned to the supplier for evaluation.Upon evaluation, the device was found to be according to specifications.There were no burrs present as reported by the user facility.No additional issues have been reported.

• Brand Name: CLOSED-END KNOT PUSHER
• Type of Device: KNOT PUSHER
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18913929
• MDR Text Key: 337780347
• Report Number: 1923569-2024-01004
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403156342
• UDI-Public: 10885403156342
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-6300
• Device Catalogue Number: 89-6300
• Device Lot Number: L23VEO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1