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)
Date of Event	09/12/2022
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 leaking around the plunger while the product was being used to mix nicardipine.
Additional Manufacturer Narrative
The device history record (dhr) review showed pieces were visually inspected and physically tested with no issues recorded relating to this customer report.The manufacturing site received one used sample with an orange apparatus attached to the taper of the syringe.A visual inspection was performed showing no issues observed.A leak test was performed with and without the orange apparatus on the syringe, and no leakage was observed around the plunger.As a result of the current investigation, there were no manufacturing-related problems confirmed in relation to the syringe assembly.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time a capa will not be initiated.This complaint will be used for 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: 15417239
• Report Number: 1915484-2022-01291
• Device Sequence Number: 6554422
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 211533X
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown