MAUDE Adverse Event Report: UNKNOWN ORAL SOLUTION SYRINGE; SYRINGE, PISTON

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Description

I entered a report on the pso website, i assume you see all events reported to ecri and the (b)(4).Your submission event id: (b)(6) event type: medication related while performing medication safety rounds, it was discovered that the l.E.T.(lidocaine, epinephrine, tetracaine) topical gel syringes were packaged in an oral solution syringe.Upon further investigation, it was discovered these syringes were purchased from (b)(4).(b)(4) manufactures, produces and distributes the l.E.T.Topical gel syringes in what appears to be an oral syringe.Despite the topical gel and for external use labeling on the product, supplying the end product in an oral syringe is a patient safety error waiting to happen.Manufacturer/labeler poor product design: (i.E.Vial, syringe, bag) (b)(6).

• Brand Name: ORAL SOLUTION SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16628133
• MDR Text Key: 312445584
• Report Number: MW5116018
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1