MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3ML SFTY COMBO 25X1; SYRINGE, PISTON

Model Number	8881833510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
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 while drawing up a vaccine from a vial, there must have been too much pressure and the syringe backed off the needle and vaccine went all over the place, could say it "exploded".Additional information was received and stated that when drawing up the mmr vaccine into the syringe, it felt a little more difficult, almost like there was a pull from the other direction, but the vaccine was still slowly pulling to the syringe and the plunger was moving and suddenly, the needle backed off the syringe and pushed the syringe away from the needle; vaccine blew out of the syringe and needle.The needle was still in the vial stopper and the syringe was lying on the counter and felt as if there was too much pressure in the vial or syringe.There was no harm occurred.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 09-jul-2021.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X1
• Common Device Name: SYRINGE, PISTON
• 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: 14177254
• Report Number: 1017768-2022-01009
• Device Sequence Number: 17399466
• Product Code: FMF
• UDI-Device Identifier: 10192253024746
• UDI-Public: 10192253024746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 8881833510
• Device Catalogue Number: 8881833510
• Device Lot Number: 118056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown