MAUDE Adverse Event Report: CAREFUSION INC. HENLY RETRACTOR SET

Model Number	CH1030
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The henly retractor set subject of the reported was 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, the blades to their henly retractor were not "locking on" and "sliding off" during use.User facility personnel stated the patient procedure was completed successfully and no injuries were reported.
Additional Manufacturer Narrative
The henly retractor set subject of the reported was returned for evaluation.Evaluation of the device determined that no issues were noted with the function or operation.The device operated according to specifications and the reported event could not be duplicated.The device history record (dhr) was reviewed and confirmed the device was manufactured to specification; no abnormalities were noted.A complaint review was performed and confirmed this event to be isolated for the lot subject of the reported event.No additional issues have been reported.

• Brand Name: HENLY RETRACTOR SET
• Common Device Name: HENLY RETRACTOR SET
• 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: 19086820
• Report Number: 1423507-2024-01011
• Device Sequence Number: 7651985
• Product Code: DWS
• UDI-Device Identifier: 10885403023064
• UDI-Public: 10885403023064
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/11/2024

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: CH1030
• Device Catalogue Number: CH1030
• Device Lot Number: A24XBH
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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