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	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the associate engaged the safety device and heard the "click".She went to dispose of the syringe and the safety had slid down enough that the needle was in fact uncovered.This resulted in a dirty needlestick on the side of her finger.Additional information received on 19feb2024 stated that no first aid or prophylactic treatment was provided.The associate did have blood work done and they have the results but the initial reporter does not have access to that information.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
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.There were two photos provided however the clarity of the pictures are very dark and no defects can be observed.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: 18848506
• Report Number: 1915484-2024-00004
• Device Sequence Number: 7439233
• 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): 03/28/2024

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: 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: 03/28/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown