MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 35ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1183500777
Medical Device Problem Code	Break (1069)
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 broken syringe tips.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A physical sample was not received for the investigation, but photos were provided.The photos were reviewed, and the reported condition was confirmed; broken luer tips were observed.Based on all available information, a definitive root cause could not be determined at this time.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.If a physical sample is received at a later date, the investigation will be reopened and updated accordingly.A corrective action is not applicable at this time.However, the reported condition will be communicated to the appropriate quality and manufacturing personnel to heighten awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 35ML 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: 16547322
• Report Number: 1915484-2023-01310
• Device Sequence Number: 14939056
• Product Code: FMF
• UDI-Device Identifier: 10192253034691
• UDI-Public: 10192253034691
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/10/2023

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: 1183500777
• Device Catalogue Number: 1183500777
• Device Lot Number: 217145X
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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