MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while mixing for non-hd compounds, compounding pharmacy technician noticed a couple syringes had a bad seal on the black plunger of the monoject 20ml syringe causing medication to leak out of the syringe once he started to withdraw.The item was monoject 20 ml syringe luer-lock tip, reference number: 1182000777, lot number: 314254x.This did not affect patient care as the correct volume was withdrawn with a new syringe for compounding.Multiple syringes with the same lot number were tested using non-drug diluents, and leakage was observed.Identical products with matching lot number were removed and was not further used.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device history record for the lot reported indicates that product and specification requirements were met with no non-conforming product identified during manufacturing.Twenty sealed samples were received for evaluation.No issues were identified during a visual inspection and all twenty syringe samples passed restriction and leak testing.There were no bad seals observed on the syringe samples received for product analysis.Without a representative sample for bad seal on the black plunger (tip), a root cause for the leaking syringe cannot be determined.No actions are required at this time.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: MONOJCT 20ML 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: 19041349
• Report Number: 1915484-2024-00008
• Device Sequence Number: 8471643
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 314254X
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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