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)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the tip is breaking off in the iv connecting tubing.
Additional Manufacturer Narrative
A possible lot number is 22a16.This is the lot number on the syringes that are in the same bin the syringe with the issue was taken from.An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing no indication of deviations.The photo received from the customer shows the luer lock tip broken off in the iv connecting tubing.Two samples were received for evaluation.One unused piece, and 1 used piece were returned.The returned samples were visually checked.For the unused syringe, there were no deviations or issues in any component and the luer lock tip was not broken.For the used syringe, it was found that the luer lock tip was broken off in the female connector.Based on the investigation, there were no abnormalities of the product, and all measured results of the retained samples were within specification.The returned samples were in compliance as well.It is believed that the broken syringe was caused from excessive torque force during use.No new actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• 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: 15209296
• Report Number: 1282497-2022-10713
• Device Sequence Number: 2199342
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/27/2022
• 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