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BD Perisafe™ 409442Recalls & reported problems

Becton, Dickinson And Company · NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382904094423), received between Sep 29, 2021 and Oct 24, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Complete Blockage1
  • Leak/Splash1
  • Material Deformation1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 24, 2023Leak/Splash; Leak/Splash

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17996598 ↗
  • MalfunctionAug 8, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

    IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL NEEDLE HUB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "MATERIAL DEFECTIVE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15182954 ↗
  • MalfunctionSep 29, 2021Complete Blockage; Complete Blockage

    IT WAS REPORTED NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE HAD A BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AT THE TIME OF STARTING THE BLOCKAGE, THE MEDICAL AND NURSING STAFF NOTICED THE BAD STATE OF THE NEEDLE, SO THEY PROCEEDED TO MAKE THE CHANGE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12550205 ↗

Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices

All NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices →

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