MAUDE Adverse Event Report: CAREFUSION INC. CARMALT ARTERY FORCEPS

Model Number	SU2775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The device was returned to the supplier for evaluation.It was determined that the breakage of the forceps was likely due to internal stress caused by excess force.The device history record was reviewed for this lot and no abnormalities were found.This is considered an isolated event.No additional issues have been reported.

• Brand Name: CARMALT ARTERY FORCEPS
• Common Device Name: 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
• Report Number: 1423507-2024-01010
• Device Sequence Number: 11731441
• Product Code: GEN
• UDI-Device Identifier: 10885403064487
• UDI-Public: 10885403064487
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: SU2775
• Device Catalogue Number: SU2775
• Device Lot Number: I23XMR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown