MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 60ML SYR L-LOCK RP; SYRINGE, PISTON

Model Number	8881560125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the luer-lock tip broke off and remained inside the tip cap when the rn (registered nurse) was going to administer.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: from the photos provided, broken off luer tips were observed.The device history records were reviewed and indicated that the product and specification requirements were met with no non-conforming product identified.Based on all available information, an exact root cause could not determined.All information received will be used for further tracking and trending purposes.

• Brand Name: MONOJCT 60ML SYR L-LOCK RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19710976
• Report Number: 1423537-2024-00070
• Device Sequence Number: 8920356
• Product Code: FMF
• UDI-Device Identifier: 20884521012230
• UDI-Public: 20884521012230
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: 406129X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/23/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown