MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3MLSFTY COMB 22X1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the package was opened and the needle end was found broken apart.The second package opened had the same finding.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 010467 indicates that the functional samples were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were 2 samples (unused) returned with this complaint.The samples were evaluated by a visual inspection confirming the reported condition.The most plausible root cause is that the assembly path was partially blocked as units were being cingulated onto the subsequent conveyor belt from the turrets that combine the needle assemblies and syringes; this could have caused the units to significantly bend without breaking and continue to packaging.Prior to a lot¿s release, the lot must be deemed acceptable, passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, both the needle assemblies and the syringes were inspected for component damage (functional).The lot met all defined acceptance requirements and was released.The inspection standard will be updated to reflect the inspection of damaged product for the combo assembly.The packager will also be examined for potential improvement that will differentiate between different levels of damage associated with risks.This information will be utilized for trending purposes to determine the need for additional corrective actions.

• Brand Name: MAGELLAN 3MLSFTY COMB 22X1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• 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: 13560675
• Report Number: 1017768-2022-00998
• Device Sequence Number: 4299393
• Product Code: FMI
• UDI-Device Identifier: 10884521005792
• UDI-Public: 10884521005792
• 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): 09/06/2022

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: 010467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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