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

Model Number 1180300777

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

• Brand Name: MONOJCT 3ML SYR L-LOCK
• Type of Device: 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
• MDR Text Key: 328005540
• Report Number: 1017768-2023-01107
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2023

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: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 23E259
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Type of Device Usage: A
• Patient Sequence Number: 1