MAUDE Adverse Event Report: INTL. MEDICAL INDUSTRIES ORAL TAMPER EVIDENT CAP; DISPENSER, LIQUID MEDICATION

Model Number 57-70 IMI

Device Problems Break (1069); Application Program Problem: Medication Error (3198)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Tamper evident cap broke of in tip of oral syringe preventing medication administration.

• Brand Name: ORAL TAMPER EVIDENT CAP
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): INTL. MEDICAL INDUSTRIES; 2981 gateway drive; pompano beach FL 33069
• MDR Report Key: 17002649
• MDR Text Key: 315937560
• Report Number: 17002649
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57-70 IMI
• Device Catalogue Number: 57-70 IMI
• Device Lot Number: 45138
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1