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

Model Number	8881850510
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
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 she was getting a flu vaccine ready for administration.As she was attaching the needle there was a clicking sound which at the time, she thought nothing of, as the needle she had attached are not the ones they normally have ordered to their office, and so she thought it was just the needle clicking into place.She believed that was the moment that the hub of the needle she was using cracked.As she was unaware of the crack and did not see any deformities or issues with any part of the needle, she went along with administering the flu shot to the patient.Upon pushing the plunger to deliver the flu shot, the fluid, instead of going through the needle, came through the crack in the hub of the needle.She gave the patient some paper towels, as he now had most if not all of a flublok vaccine dripping down his left upper arm.Md aware and instructed her, so long as the patient was okay with it, to give the flu shot again as it was unlikely, he got any of the previous one.The patient got the new flu shot ready, using the needles they regularly have ordered to the office and administered as usual.
Event or Problem Description
The customer reported that she was getting a flu vaccine ready for administration.As she was attaching the needle there was a clicking sound which at the time, she thought nothing of, as the needle she had attached are not the ones they normally have ordered to their office, and so she thought it was just the needle clicking into place.She believed that was the moment that the hub of the needle she was using cracked.As she was unaware of the crack and did not see any deformities or issues with any part of the needle, she went along with administering the flu shot to the patient.Upon pushing the plunger to deliver the flu shot, the fluid, instead of going through the needle, came through the crack in the hub of the needle.She gave the patient some paper towels, as he now had most if not all of a flublok vaccine dripping down his left upper arm.Md aware and instructed her, so long as the patient was okay with it, to give the flu shot again as it was unlikely, he got any of the previous one.The patient got the new flu shot ready, using the needles they regularly have ordered to the office and administered as usual.Additional information was received from the customer and stated that there wasn't any contaminated needle stick occurred.The patient still follows with the doctor and no further complaint has been made as far as the director knows.
Additional Manufacturer Narrative
The following sections were updated or answered: d1: brand name; d3: manufacturer name and address; d4: unique identifier (udi) #; d4: expiration date #; g4: pma/510(k)number; h6: evaluation codes.Investigation summary: samples were not received, for the investigation.The device history record was reviewed and indicated, that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm, the reported issue and determine a root cause.A corrective action is not applicable at this time.This complaint will be used for 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: 18434886
• Report Number: 1017768-2024-00001
• Device Sequence Number: 7155319
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: (01)10884521000568(17)271031(10)22M190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 22M190
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023; Not provided
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/11/2024; 11/14/2024
• 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