BD Perisafe™ 405164Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382904051648), received between Nov 23, 2022 and Feb 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Incomplete or Inadequate Connection

  ADDITIONAL INFORMATION: COULD YOU TELL US HOW MANY UNITS HAVE BEEN AFFECTED? 3 UNITS. COULD YOU CONFIRM THE BATCH NUMBER OF THE SAMPLE? 4323628. COULD YOU TELL US THE DATE OF THE INCIDENT IN DD/MM/YYYY? 10/01/2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345553 ↗
• MalfunctionMay 10, 2024Leak/Splash; Leak/Splash

  TODAY DEXCO NOTIFIES THAT IN THE (B)(6) CLINIC THERE IS A DISSATISFACTION ON THE PART OF THE GROUP OF ANESTHESIOLOGISTS OF THE INSTITUTION REGARDING THE USE OF THE BD SPINAL PROBE, FOR WHICH THEY ARE RETURNING THE ORDER AWARDED BY BIONEXO. THE MAIN CAUSE FOR CONCERN IS THE LEAKAGE OF MEDICATION BETWEEN THE THREAD OF THE SPINAL PROBE AND THE SYRINGE (PRECISION CARE) USED TO ADMINISTER THE MEDICATION DURING THE PROCEDURES, AND THEY ALSO REPORT THAT THESE NEEDLES, WHICH WERE DELIVERED BY ANOTHER DISTRIBUTOR, ARRIVED WITH A DEFORMITY IN THEIR PRIMARY PACKAGING (CURVATURE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287311 ↗
• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL AND SYRINGE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "WHEN THE SYRINGE IS CONNECTED TO THE NEEDLE, THE MEDICATION LEAKS AND MUCH OF IT IS LOST, THE SYRINGE IS NOT WELL ATTACHED TO THE NEEDLE, WHICH CAUSES MUCH OF THE MEDICATION TO BE LOST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541744 ↗
• MalfunctionJul 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD QUINCKE WHITACRE SPINAL INTRODUCER NEEDLE LEAKED WHEN PARING THE SYRINGE AND NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WHEN PAIRING SYRINGE WITH ANESTHESIA IN THE NEEDLE THE MEDICINE IS SPILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322175 ↗
• MalfunctionNov 23, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL LEAKED MEDICINE FROM THE SYRINGE CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE ANESTHESIOLOGISTS SAY THAT THE SYRINGE DOES NOT FIT THE NEEDLE AND LEAKS WHEN THE MEDICINE LEAVES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859394 ↗