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

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	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they were giving the patient winrho im and as the writer pushed the plunger on the syringe, medication shot out where the syringe met the needle.The syringe was checked prior to giving the dose and was connected correctly.They were unsure how much medication the patient received, so they had to give a second dose.The leak occurred at the gray area.No injuries occurred.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.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, samples are inspected for leaking.The shop orders used for this lot met all defined acceptance requirements and were released.One decontaminated sample was received at the manufacturing site for the investigation.Visual and functional evaluations were performed, and the reported condition could not be confirmed; the sample was tested for leaking and no issues were observed.A root cause could not be determined based on all available information as the reported issue was not confirmed.There were no anomalies found during a review of the dhr¿s, maintenance records, or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be utilized for tracking and trending purposes to determine the need for 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: 13653765
• Report Number: 1017768-2022-00999
• Device Sequence Number: 2481645
• Product Code: FMI
• 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): 06/01/2022

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: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown