MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT; SYRINGE, PISTON

Model Number	8881513702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported it appeared that the syringe had a broken and missing tip.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 23b135 was reviewed and no anomalies related to the reported issue were observed.The lot was manufactured between 17feb2023 and 20feb2023.One device was received for analysis and the reported issue was observed.However, the true root cause could not be determined based on available information.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20313936
• Report Number: 1423537-2024-00173
• Device Sequence Number: 20740845
• Product Code: FMF
• UDI-Device Identifier: 20192253037835
• UDI-Public: (01)20192253037835
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K945715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 8881513702
• Device Catalogue Number: 8881513702
• Device Lot Number: 23B135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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