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Boject 9013S0422Recalls & reported problems

Natus Manufacturing Limited · Bo-ject Needle · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830042420), received between Dec 12, 2018 and Dec 13, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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

Device problems

  • Break2
  • Material Separation1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 13, 2018Break; Material Separation; Break; Material Separation

    ADDITIONAL INFORMATION: DURING PROCEDURE TO INJECT BOTULINUM TOXIN IN THE RIGHT MEDIAL HAMSTRING THE NEEDLE BROKE REQUIRING SURGICAL INTERVENTION TO RETRIEVE THE NEEDLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8160267 ↗
  • MalfunctionDec 12, 2018Break

    DURING PROCEDURE TO INJECT BOTULINUM TOXIN IN THE RIGHT MEDIAL HAMSTRING THE NEEDLE BROKE REQUIRING SURGICAL INTERVENTION TO RETRIEVE THE NEEDLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8154542 ↗

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