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

Medical Device Problem Code	Fluid/Blood Leak (1250)
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 an issue regarding the use of the safety needle and stated "ampule bags/pfs/vial leaks." the product information was not provided.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.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 the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Additional event information was received from the customer on 09jun2024 therefore section b5 was updated.H6 health effect - impact code was also updated.
Event or Problem Description
The customer reported an issue regarding the use of the safety needle and stated "ampule bags/pfs/vial leaks".On 09jun2024 the customer provided additional information stating that after the injection, the nurse noticed that the syringe had melted at the screw thread.The nurse therefore declared that a large quantity of the product had leaked out and had not been injected.The patient did not receive another injection: he is under observation and will receive tablets if necessary.Possible item code 8881850215, 8881850310.Possible lot number 004115, 113789.
Additional Manufacturer Narrative
Based on additional information received on 11oct2024, 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.At this time, our investigation is currently still underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Pictures were received, and the reported issue was observed.However, a definitive root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 18961997
• Report Number: 1017768-2024-00032
• Device Sequence Number: 8161737
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: (01)10884521000087(17)241231(10)004115
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/16/2024

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 Expiration Date: 12/31/2024
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 03/29/2024; 06/12/2024; 10/11/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown