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

Model Number	8881560125
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip broke off during infusion, and led to medication leaking out and not being administered to the patient.Additional information received on 22jul2024 stated that the patient received a dose, but the dose was delayed as this one leaked when attaching to the patient.The medication had to be remade in another syringe.There was no harm or injury to the patient due to this incident.
Additional Manufacturer Narrative
Additional information was received from the initial reporter on 22jul2024 therefore additional event information was added to section b5.Additional information was received from the initial reporter on 22jul2024 therefore section h6 health effect - impact code was corrected from missed dose to delay to treatment/ therapy.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the tip broke off during infusion, and led to medication leaking out and not being administered to the patient.
Additional Manufacturer Narrative
Investigation summary: samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• 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; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19795241
• Report Number: 1423537-2024-00080
• Device Sequence Number: 20632890
• Product Code: FMF
• UDI-Device Identifier: 20884521012230
• UDI-Public: (01)20884521012230(10)308019X
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945715
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: 308019X
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown