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

Model Number	8881850310
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
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 when the needle was attached to the syringe, there was a small noise.When she started to inject, the product escaped from the syringe and bubbles appeared between the syringe and the needle.The nurse stopped the treatment and found that the needle protection had lost a piece of plastic and was cracked.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were not returned with this complaint, but two pictures were provided.One picture shows the top of the blue hub cracked.The other picture showed the cracked blue piece of the hub in the thread of the syringe.Pharmathen syringes were received from the customer for further assessment.The investigation determined that when applying additional force while attaching the customer¿s syringe to the magellan safety needle the hubs would sometimes crack.A definitive root cause could not be determined at this time.However, actions have been implemented to address the observed condition.All information received will be used for further tracking and trending purposes and we will continue to monitor.

• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20085219
• Report Number: 1423537-2024-00138
• Device Sequence Number: 18032742
• Product Code: FMI
• UDI-Device Identifier: 10884521000544
• UDI-Public: (01)10884521000544(17)270331(10)22E197
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 11/15/2024

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: 8881850310
• Device Catalogue Number: 8881850310
• Device Lot Number: 22E197
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown