BD Molecular Swab Collection Kit 443925Recalls & reported problems
Becton, Dickinson And Company · Molecular Swab Collection Kit 100EA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904439255), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED WHILE USING BD MOLECULAR SWAB COLLECTION KIT, ONE SWAB WAS CUT BY A TECHNICIAN TO FIT INSIDE THE TUBE AND THE PATIENT SAMPLE AND REAGENT SPLASHED INTO THEIR EYE. TECHNICIAN WAS TREATED BY OCCUPATIONAL MEDICINE AND RECEIVED ANTIBIOTIC EYE DROPS. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE BADLY BROKEN SWAB (TOO LARGE) PREVENTED THE BD MAX MACHINE FROM PIPETTING CORRECTLY (BD MAX ERROR AND STOPPAGE OF THE ENTIRE SERIES, WHICH HAD TO BE RESTARTED IN ITS ENTIRETY). THE TECHNICIAN CONCERNED HAD TO OPEN THE TUBE TO RECUT IT. WHEN SHE RECUT THE TUBE, IT SPLASHED INTO HER EYE. THESE WERE PROJECTIONS OF GENITAL SWABS. SHE WAS TREATED BY OCCUPATIONAL MEDICINE. DURING OUR SURVEY, OUR USERS TOLD US THAT THEY HAD NOTICED THE RISK OF SPLASHING AND THE PROBLEM OF BREAKAGE WHEN THEY BROKE THE SWABS, WHICH THEY DID BY MOVING THE TUBE AS FAR AWAY FROM THEM AS POSSIBLE, PRECISELY TO AVOID SPLASHING." 1. COULD YOU PLEASE EXPLAIN THE AES THAT HAPPENED? "WHEN THE SAMPLE WAS BEING TAKEN FROM THE BD MAX, THE PLC WENT INTO ALARM BECAUSE THE SWAB WAS TOO LONG. THE TECHNICIAN CUT THE SWAB AND THIS LED TO A SPLASH IN THE EYE. " 2. COULD YOU PLEASE CONFIRM WHETHER THERE WAS ANY SPL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106856 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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