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

Model Number	8881520673
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
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 the tip is broken on the syringes in the sealed case.They found several in the unit.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The lot was manufactured and packaged on nov.15-16, 2021.The manufacturing site received one photograph for product analysis.The photo shows the top half of what appears to be a 20ml regular luer slip syringe in the sleeve.The luer tip of the syringe barrel can be observed broken off from the syringe inside the sleeve.One packaged 20ml regular tip syringe in cap and sleeve was received for evaluation.A visual inspection to the quality inspection standard was conducted.A broken-off luer tip inside the syringe sleeve was identified.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.The exact root cause was not able to be determined based on the available information however a quality alert will be distributed to the appropriate quality and manufacturing personnel to heighten awareness of the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 20ML SYR L-SLIP RP
• 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: 16233137
• Report Number: 1915484-2023-01308
• Device Sequence Number: 6475109
• Product Code: FMF
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 8881520673
• Device Catalogue Number: 8881520673
• Device Lot Number: 129876X
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/22/2023
• 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