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

Model Number	1181200777T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: an incident happened on the evening of (b)(6) 2023 involving 12-ml syringes that were used by the nurse while drawing blood from a venous sheath on a new admittance in room 2722.The luer lock of two 12-ml syringes broke off during routine handling of the items.The 1st syringe had a blunt needle attached to it.When the nurse unscrewed the needle, the luer lock came with it.The 1st syringe was used to draw blood and had no issues when unscrewed from the port of the venous sheath.The 2nd syringe was used to draw blood from the same port and when unscrewed, the luer lock broke off and remained stuck inside the port.There were no further issues reported related to the use of other 12-ml syringes for the rest of the shift.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because it was discarded.
Additional Manufacturer Narrative
The documents from the reported lot was reviewed and there is no historical documentation that indicate any deviations.A photo was provided of the packaging, but the photos do not display the condition reported therefore no root cause could be determined from the photographs.Ten retained samples from the reported lot were visually evaluated.There were no deviations or abnormalities in any of the components and the luer lock tips were not broken on any of the retained samples.The dimensions and taper at luer lock tip of syringes were measured.All measured results complied with the criteria for iso standards.We surmised that the broken syringe luer lock may have been caused from excessive torque force during use.Corrective actions will not be implemented at this time.

• 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: 16762169
• Report Number: 1282497-2023-10751
• Device Sequence Number: 14218448
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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
• Device Lot Number: 22F19
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown