MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850558
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/28/2023
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 they had a needlestick accident due to the safety needle not locking properly.The needle lock device failed, and retracted when they placed the syringe in the sharps container.They then poked their left index finger.The needle had been used on a patient.They tried it again on another needle and the security device failed to engage.They were treated in the er and will follow up with employee health services.Additional information received on 02-nov2023 confirmed that the second needle was a clean needle.Information regarding if treatment was required is pending.
Additional Manufacturer Narrative
Investigation summary: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.The lot was produced between 08aug2023 and 09aug2023.No samples were returned for evaluation.However, a video was provided and reviewed.The reported condition could not be confirmed based on the provided video and an exact root cause cannot be determined.Based on the investigation and root cause analysis, the initiation of a corrective and preventative action is not applicable at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18212620
• Report Number: 1017768-2023-01110
• Device Sequence Number: 17753572
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: (01)10884521000575(10)23H130(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 23H130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 09/26/2024
• 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: Female