MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN TB 1 ML 28G X 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881882812
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
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 while in the operating room, the doctor attempted to use the magellan 1ml tuberculin safety syringe to draw up medication for the patient's spinal anesthesia and when pulling off the cap, the safety mechanism disengaged preventing him from drawing up the medication.This happened with multiple syringes.No patient injury was reported.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The product was manufactured and packaged on may 27, 28, 31 and june 1, 2021.Two 1ml magellan tuberculin 28g x ½ syringes in opened blister strip packaging identified with lot 116536x were received.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.The blue safety sheath was not fully seated on the safety shield of the syringe samples received.The plunger/rubber tip was extended from the syringe barrel on one of the syringe samples, and it would not retract back into the syringe when pressure was applied to the plunger rod.This indicates that the cannula is occluded.The blue safety sheath was removed for evaluation of the cannula on each of the syringe samples received.Pulled lock insert was identified on each of the syringe samples; one was almost completely detached from the syringe.The reported condition was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.A corrective and preventative action plan has been initiated to address the reported condition.This complaint will be used for tracking and trending purposes.Correction made to contact office - manufacturing site address.

• Brand Name: MAGELLAN TB 1 ML 28G X 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16296918
• Report Number: 1017768-2023-01044
• Device Sequence Number: 12649622
• Product Code: FMI
• UDI-Device Identifier: 10884521005921
• UDI-Public: 10884521005921
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 8881882812
• Device Catalogue Number: 8881882812
• Device Lot Number: 116536X
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/27/2023
• 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