MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON

Model Number	1180325100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	02/14/2024
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 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.
Additional Manufacturer Narrative
The following sections were updated or answered: d1 brand name; d3 manufacturer name and address; d4 unique identifier (udi) #; g4 pma/510(k)number; h5 labeled for single use? h6 evaluation codes.Investigation summary: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.¿ as such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• 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
• Report Number: 1017768-2024-00012
• Device Sequence Number: 15265382
• Product Code: FMF
• UDI-Device Identifier: 10884521012431
• UDI-Public: (01)10884521012431(10)025850
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K852544
• 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): 01/30/2025

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: 1180325100
• Device Catalogue Number: 1180325100
• Device Lot Number: 025850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown