MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY 3ML, 23 X 1; SYRINGE, PISTON

Model Number	11832310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
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 but did not provide rationale.
Event or Problem Description
Customer reports: healthtrust wants us to do an investigation regarding lot 01104020.According to them, the needles are loose on the syringe.Additional information provided on (b)(6) 2023 stated that although they have not had a needlestick, er staff have expressed concerns regarding the needles being loose and falling off.
Additional Manufacturer Narrative
Per additional information received on (b)(6) 23, the following fields have been updated.Section b5 - description summary initially, it was reported that there were no needle sticks, however there was one contaminated needle stick that occurred.Section h6 - health effect clinical code initially was coded as: 4582 and should have been coded as 2462.
Event or Problem Description
Per additional information received on (b)(6) 23, the needle fell off following the injection and employee attempted to grab it.It did not need removed from the patient.Previously, it was reported that there was no needle stick, however it has been communicated that one contaminated needle stick did occur with a staff member.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.Based on historical data a corrective and preventive action has been initiated to address the reported issue.

• Brand Name: MONOJECT SAFETY 3ML, 23 X 1
• 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: 17024967
• Report Number: 1282497-2023-10761
• Device Sequence Number: 15344900
• Product Code: FMF
• UDI-Device Identifier: 10884521544567
• UDI-Public: 10884521544567
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/11/2023

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: 11832310
• Device Catalogue Number: 11832310
• Device Lot Number: 01104020
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 05/17/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/05/2023; 08/11/2023
• 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