MAUDE Adverse Event Report: CAREFUSION INC. CARMALT ARTERY FORCEPS

Model Number SU2775

Device Problem Break (1069)

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

Event Date 03/04/2024

Event Type  malfunction  

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.

Event Description

The user facility reported that during a patient procedure their carmalt artery forcep broke while trying to clamp an umbilical cord after the delivery of a baby resulting in a delay of clamping the cord.Another clamp was retrieved and the procedure was completed successfully.No report of injury.

• Brand Name: CARMALT ARTERY FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19020775
• MDR Text Key: 339128751
• Report Number: 1423507-2024-01010
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403064487
• UDI-Public: 10885403064487
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SU2775
• Device Catalogue Number: SU2775
• Device Lot Number: I23XMR
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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