MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 6ML SYR L-LOCK RP; SYRINGE, PISTON

Model Number	8881516937
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they draw the fluid into the syringe and when injecting the fluid into the patient, the syringe stops between the 2 and 1 ml marker.Per additional information received on 29-mar-2022, the plunger was sticking.After switching the medication from depo-medrol to triamcinolone, no further issues occurred.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed syringes were visually inspected and physically tested with no issues found.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.There were no photographs or physical samples received for product analysis.Without a sample, an investigation cannot be performed, and the reported condition cannot be confirmed.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and the packaging processes, and to ensure components and finished product meet all quality inspection standards (qis) during the syringe assembly processes.Per procedure, 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.However, the reported condition will be communicated to the appropriate quality and manufacturing personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 6ML SYR L-LOCK RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• 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: 14085244
• Report Number: 1915484-2022-01276
• Device Sequence Number: 5289335
• Product Code: FMF
• UDI-Device Identifier: 10884521014190
• UDI-Public: 10884521014190
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 8881516937
• Device Catalogue Number: 8881516937
• Device Lot Number: 135449X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2022
• Supplement Date Received by Manufacturer: 03/20/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown