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BD Intelliport 516700Recalls & reported problems

Becton, Dickinson And Company · SENSOR · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382905167003), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Communication or Transmission Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT SENSOR HAD SCREEN ISSUES WITH THE TABLET.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516700, BATCH NO. UNKNOWNIT IS REPORTED CUSTOMER EXPERIENCED SCREEN ISSUES WITH TABLET.VERBIAGE RECEIVED, - SENOR #9302 WAS PREPARED ACCORDING TO IFU USING TWO 10ML FLUSH SYRINGES. AFTER TWO SYRINGES, TABLET STILL DISPLAYED "CONTINUE FLUSHING" MESSAGE. CUSTOMER FLUSHED AGAIN USING TWO 5ML PUSHES FROM A THIRD 10ML FLUSH SYRINGE. TABLET STILL DISPLAYED CONTINUE FLUSHING" MESSAGE, SO CUSTOMER GOT A FOURTH 10ML FLUSH SYRINGE AND PUSHED TWO MORE 5ML PUSHES. TABLET STILL DISPLAYED A "CONTINUE FLUSHING" MESSAGE. AT THAT POINT, THE CUSTOMER SET THE SENSOR ASIDE AND OPENED A NEW ONE. THE NEW SENSOR TURNED TO "READY" STATE AFTER ONLY ONE 10ML FLUSH SYRINGE WAS USED TO PREP.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 11276906 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.