MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 12ML SYR LUER-LOCK; SYRINGE, PISTON

Model Number	1181200777T
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 that the tip of the luer lock syringes were breaking off in the tubing connection.The customer has worked with the pharmacy and newborn intensive care unit (nicu) to investigate this issue.Per customer, at first, they thought it was associated with an antibiotic being infused through the microbore tubing but they came to find out this is happening with all different medications.The customer further stated that when this issue occurs, the nurse cannot flush the remaining antibiotics into the neonates.Additional information was received and stated that this is the first time the customer reporting this issue to cardinal health, as the customer had a task force investigating this issue and have ruled out other possible reasons for this occurring.
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: MONOJCT 12ML SYR LUER-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13025157
• Report Number: 1282497-2021-10661
• Device Sequence Number: 19273978
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 1181200777T
• Device Catalogue Number: 1181200777T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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