FDA Adverse Event Other Summary report: N

EYECON MACHINE

MDR report key: 18394228 · Received December 22, 2023

Report

Report Number
MW5149539
Event Type
Other
Date Received
December 22, 2023
Report Date
December 20, 2023
Manufacturer
AVERY WEIGH-TRONIX LLC
Product Code
NXB
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

A 14-YEAR-OLD PATIENT WAS MISTAKENLY PROVIDED TWO TABLETS OF HYDROCODONE-ACETAMINOPHEN ALONGSIDE THE PATIENT'S MONTELUKAST PRESCRIPTION UPON DISCHARGE. THIS ERROR OCCURRED OUTPATIENT PHARMACY WHILE PREPARING MEDICATIONS FOR THE DISCHARGED PATIENT, ONE OF WHICH WAS 12 HYDROCODONE-ACETAMINOPHEN 5-325MG TABLETS. DURING THE MEDICATION-FILLING; PROCESS, THE PRODUCT WAS SWITCHED FROM TABLET FORM (5-325MG) BY MALLINCKRODT TO LIQUID FORM (7.5-325MG/15ML) BY VISTAPHARM INC. BOTH VERSIONS WERE FILLED AND PRESENTED TO VERIFYING PHARMACIST. THE PHARMACIST SET ASIDE THE TABLET FORM OF HYDROCODONE-ACETAMINOPHEN TO RETURN THE PRODUCT TO THE AUTOMATED DISPENSING DEVICE. WHEN RETURNING HYDROCODONE-ACETAMINOPHEN TABLETS TO THE AUTOMATED DISPENSING DEVICE, THE PHARMACIST ONLY COUNTED TEN TABLETS INSTEAD OF THE EXPECTED TWELVE. A COUNTBACK WAS PERFORMED TECHNICIAN RESPONSIBLE FOR FILLING THE PRESCRIPTION AND THE COUNT WAS CORRECT IN THE AUTOMATED DISPENSING DEVICE. THE PHARMACIST REVIEWED AUTOMATED DISPENSING DEVICE REPORTS REVIEWED EYECON IMAGE. THE REPORT AND COUNTBACK DID NOT INDICATE ANY DISCREPANCY. THE EYECON IMAGE DISPLAYED THE ORIGINAL TWELVE TABLETS. THE SUBSEQUENT PRESCRIPTION FILLED EYECON FOR THE SAME PATIENT WAS MONTELUKAST, WHICH IS CAPTURED IN THE EYECON AUDIT TOOL. THE PATIENT'S FAMILY WAS CONTACTED BY THE PHARMACIST TO CONFIRM SUSPICIONS THAT TWO HYDROCODONE-ACETAMINOPHEN TABLETS HAD INADVERTENTLY FALLEN INTO THE MONTELUKAST BOTTLE AT TIME OF FILLING FROM THE EYECON. UPON CONFIRMATION, THE FAMILY WAS INSTRUCTED TO "DIS" THESE TWO HYDROCODONE-ACETAMINOPHEN TABLETS. TABLETS AND CAPSULES, SPECIFICALLY OF LARGER SIZE, HAVE HAD MULTIPLE CIRCUMSTANCES DOCUMENTED OF MEDICATION GETTING STUCK IN TH OF EYECON AT "XXXXXXXXXXX" HOSPITAL. WE HAVE A VIDEO OF THE ISSUE WE ARE SEEING. HAPPY TO FORWARD TO SOMEONE, BUT COULD NOT GET THE VIDEO TO UPLOAD HERE. (B)(6). SUBMISSION: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2292796 EYECON MACHINE DISPENSER, SOLID MEDICATION NXB AVERY WEIGH-TRONIX LLC

Patients

Seq Age Sex Outcome Treatment
1 Unknown ACETAMINOPHEN MALLINCKRODT PHARMACEUTICALS TAB ORAL 5-325MG| HYDROCODONE BITARTRATE AND| HYDROCODONE BITARTRATE AND ACETAMINOPHEN VISTAPHARM INC., LIQUID ORAL 7.5-325 MG/15 ML | MONTELUKAST SODIUM