MAUDE Adverse Event Report: CARDINAL HEALTH MAGELL INSULIN 1/2ML 30GX5/16; SYRINGE, PISTON

Model Number	8881893050
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 they have had reports of the devices coming out of the package broken.The customer provided a photo that shows the safety and cap separated from the syringe.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: the device history record (dhr) was reviewed and there were no issues found.One (1) photo and one (1) physical sample were provided for evaluation.The reported condition was confirmed; however, the exact root cause could not be determined based on the available information.All information received will be used for further tracking and trending purposes.

• Brand Name: MAGELL INSULIN 1/2ML 30GX5/16
• 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: 18848549
• Report Number: 1915484-2024-00005
• Device Sequence Number: 7485497
• Product Code: FMF
• UDI-Device Identifier: 10884521005976
• UDI-Public: 10884521005976
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/01/2024

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
• Device Model Number: 8881893050
• Device Catalogue Number: 8881893050
• Device Lot Number: 327932X
• Was Device Available for Evaluation?: Yes
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown