MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 3ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1180300777
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported several issues.The first issue is that the graduation marks on the syringes are coming off way too easily and working in the anesthesia department this actually becomes a safety risk to the patients if the graduations are coming off and the doctors are giving more medication then needed especially working with kids.Second issue is that the plungers are super flimsy.And there is no suction in the syringes.Once again this goes back to patient safety.If the doctors cannot control the rate at which they are pushing the syringes they will give the patients more medication than needed.Third issue is that medication is actually leaking because the syringe is so loose.They work with pentenyl and other dangerous drugs so also a patient safety.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.

• Brand Name: MONOJCT 3ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18126073
• Report Number: 1017768-2023-01107
• Device Sequence Number: 20762094
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/24/2024

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: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 23E259
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 07/24/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown