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

Model Number	8881160629
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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 60 ml syringes damaged.The customer provided photos that show broken luer tips and broken syringe barrels.No further information could be provided.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: from the photos provided there is evidence showing cracked and broken off luer skirts, broken off barrel finger flange and broken off luer tip.The device history record was 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 BNS
• 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: 19515228
• Report Number: 1423537-2024-00027
• Device Sequence Number: 7326715
• Product Code: FMF
• UDI-Device Identifier: 10884521010963
• UDI-Public: 10884521010963
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 8881160629
• Device Catalogue Number: 8881160629
• Device Lot Number: 217152X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown