FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDBANK TOWER

MDR report key: 24082047 · Received January 15, 2026

Report

Report Number
2016493-2026-00527
Event Type
Malfunction
Date Received
January 15, 2026
Date of Event
September 15, 2025
Report Date
January 12, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
UDI-DI
10885403517167
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 02-JAN-2024 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE RX VERIFY REQUEST WAS NOT APPEARING IN MEDBANK MYQLINK (MQL) CR. A TECHNICAL SUPPORT SPECIALIST (TSS) FOUND IN THE PATIENT ORDER LIST SCREEN THAT THE VALIDATION CODE STATUS WAS MARKED AS REJECTED. UPON REVIEWING THE FACILITY¿S MQL SETTINGS, THE RX VERIFY EXPIRATION WAS IDENTIFIED. THE TSS GUIDED THE CUSTOMER IN CR MQL RX VERIFY TO VERIFY THAT THE REQUEST HAD BEEN SUBMITTED, REJECTED BY PHARMACY STAFF, AND WOULD REMAIN ACTIVE UNTIL THE 24 HOUR PERIOD ENDED. THE CUSTOMER WAS INFORMED OF THE AVAILABLE OPTIONS: EITHER WAIT UNTIL THE 24 HOUR EXPIRATION OR EDIT THE REJECTED RX VERIFY REQUEST AND APPROVE IT. THE CUSTOMER CHOSE TO EDIT AND APPROVE THE REQUEST. THEN, THE TSS CONFIRMED IN MQL THE CUSTOMER APPROVED THE REQUEST WITH QUANTITY SET AS ONE AND THE PATIENT ORDER LIST SCREEN THE VALIDATION CODE STATUS WAS APPROVED, QUANTITY SET AS ONE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER THE VALIDATION CODE REQUESTED BY THE USER FOR 2 TABS OF OXYCODONE IR 5MG TAB DID NOT NOT SHOW IN MQL CR. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
142458 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown