MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 3ML SYR NDL 25X1; SYRINGE, PISTON

Model Number 1180325100

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the device came apart and exploded the medication all over the place.The customer stated that the needle separated from the syringe and remained inside while the medication (trt) shot out everywhere.Additional information received on 29feb2024 stated that the patient self-administers testosterone replacement therapy (trt) so this was a self injection, intra-muscular.The hub and needle remained securely attached to each other, but the hub separated from the syringe, the medication was immediately pushed out of the syringe.The needle and hub (together) remained inside the patient and was pulled from the injection site manually by grasping the hub and pulling the needle out.There was no significant injury, only a failed injection, wasted medication (one dose), mild pain at injection site, and minimal bleeding.

• Brand Name: MONOJCT 3ML SYR NDL 25X1
• Type of Device: 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: 18853050
• MDR Text Key: 337765566
• Report Number: 1017768-2024-00012
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012431
• UDI-Public: 10884521012431
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1180325100
• Device Catalogue Number: 1180325100
• Device Lot Number: 025850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Type of Device Usage: A
• Patient Sequence Number: 1