MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY 1ML, 27 X 1/2; SYRINGE, PISTON

Model Number	11812705
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	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there are issues with the needle not being properly attached to the hub.They must tighten each one that they open to avoid a possible needle stick or a needle falling off during a procedure.Additional information provided on 11/11/22 stated that there were no patient injuries because the needle is not used on patients.The lab techs use them to get the blood samples out of the blood culture bottles to plate for microbiology.There was a tech that was scratched with one of the needles when it fell off.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A review of the device history record (dhr) was completed and indicated no discrepancies.There were 20 samples received for evaluation.All 20 samples have been tested with a gauge and were found to be in conformity.After screwing the needle into the syringe, a simulation test has been performed by withdrawing water from a vial and simulating ejection and puncture of an injection simulation bearing.The results were that none of the needles detached therefore we unable to confirm the reported condition.Based on good clinical practice, the end user should make sure the needle is attached tightly to the syringe before use.There is no evidence of a trend therefore no immediate corrective action is required, and no corrective actions are planned.The supplier will continue to monitor the product for reoccurrence.

• Brand Name: MONOJECT SAFETY 1ML, 27 X 1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15819813
• Report Number: 1282497-2022-10722
• Device Sequence Number: 11930722
• Product Code: FMF
• UDI-Device Identifier: 10192253025149
• UDI-Public: 10192253025149
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/03/2023

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?: No
• Device Model Number: 11812705
• Device Catalogue Number: 11812705
• Device Lot Number: 01108028
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 02/03/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown