MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3MLSFTY COMB 22X1 1/2; SYRINGE, PISTON

Model Number	8881833215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the medication is coming out the side of the hub instead of the needle itself.It appears the hub is stripped and not engaging properly to the luer lock.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review indicated no issues were found.All scheduled maintenance and calibration activities were completed.There were 3 samples and one photo submitted for evaluation.Functional testing confirmed the reported issue.The exact root cause of the issue could not be determined.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the samples will be inspected for leaks.The lot met all defined acceptance requirements and was released.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a corrective and preventative action (capa) is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MAGELLAN 3MLSFTY COMB 22X1 1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 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: 15758803
• Report Number: 1017768-2022-01037
• Device Sequence Number: 8220954
• Product Code: FMF
• UDI-Device Identifier: 10192253024722
• UDI-Public: 10192253024722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/03/2023

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
• Device Model Number: 8881833215
• Device Catalogue Number: 8881833215
• Device Lot Number: 210879
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown