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N/A 4541Recalls & reported problems

Carefusion 2200, Inc · Paracervical/Pudendal Block Tray - 10 ml Control Syringe with Pistol Grip · 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 10885403143250), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 16, 2018Break; Material Integrity Problem

    PUDENDAL TRAY SYRINGE BROKE DURING PROCEDURE. PER PHYSICIAN'S REPORT, THIS IS THE THIRD SYRINGE THAT HAS BROKEN IN THIS FASHION THAT SHE IS AWARE OF RECENTLY. WHEN PLUNGER IS PRESSED THE PIECE HOLDING THE PISTOL GRIP IN PLACE BROKE. PHOTOS ATTACHED TO THIS REPORT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7432480 ↗

Other SET, ANESTHESIA, PARACERVICAL devices

All SET, ANESTHESIA, PARACERVICAL devices →

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