MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 1ML TB SYR L-LOCK; SYRINGE, PISTON

Model Number	1180100777
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 they have noticed new packaging in the past two weeks and the black plunger now has two lines that make it difficult to read the exact measurement, and the fluid is bubbling up more.Nurses are also calling to say that the syringe is not working with their pumps.
Additional Manufacturer Narrative
This report was filed in error.Cardinal health is not the legal manufacturer of this device.The legal manufacturer is jiangsu caina medical co., ltd in jiangsu, china.The manufacturer has been notified of the event.

• Brand Name: MONOJCT 1ML TB SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17487813
• Report Number: 1915484-2023-01326
• Device Sequence Number: 7872038
• Product Code: FMF
• UDI-Device Identifier: 10884521013414
• UDI-Public: 10884521013414
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 1180100777
• Device Catalogue Number: 1180100777
• Device Lot Number: 230201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown