MAUDE Adverse Event Report: CARDINAL HEALTH MAGELL INSULIN 1/2ML 29GX1/2; SYRINGE, PISTON

Model Number	8881892950
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that two associates tested a clean unused needle.They engaged the safety device and heard the "click".They went to dispose of the syringe and the safety had slid down enough that the needle was in fact uncovered.No injury was reported.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event as no samples were returned for evaluation and the device history record was reviewed indicating that the product was released accomplishing all quality standards.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: MAGELL INSULIN 1/2ML 29GX1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18848988
• Report Number: 1915484-2024-00006
• Device Sequence Number: 20692697
• Product Code: FMF
• UDI-Device Identifier: 10884521005945
• UDI-Public: 10884521005945
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: 8881892950
• Device Catalogue Number: 8881892950
• Device Lot Number: 324830X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/29/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown