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	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 are having an issue with some of the safety needle.They stated that it is not every one but it is happening on a regular basis.The customer stated there has been no impact or injuries at this time.Additional information provided on (b)(6) 2024 stated that the issue is that when placing the safety mechanism over the top of the needle, the needle is not completely covered.The sharp end of the needle is still out past the cover.
Additional Manufacturer Narrative
Investigation summary: based on the information available to us, we were able to confirm the event, and determined that: although no physical samples were returned for evaluation, the complaint was confirmed after analyzing the photos provided.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A true 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: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 777 west street; mansfield MA 02048
• 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: 19168587
• Report Number: 1017768-2024-00039
• Device Sequence Number: 15441165
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: (01)10884521000575(17)281231(10)24C131
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/05/2024

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: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 24C131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown