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Broselow 7700WINRecalls & reported problems

Carefusion Corporation · Broselow&#8482 /Hinkle Pediatric Emergency System White Intubation Module · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10885403423550), received between Dec 5, 2022 and Jun 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Component Missing1
  • Patient-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJun 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BROSELOW, INTUBATION MOD, WHITE, 2PK CONTAINS AN ADULT SIZE STYLET (10FR) THAT IS TOO BIG FOR THE PEDIATRIC ENDOTRACHEAL TUBES THAT CAN CAUSE A DEADLY OUTCOME. FURTHERMORE, THERE IS NO PATIENT ASSOCIATED WITH THE SAID EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17206470 ↗
  • InjuryDec 5, 2022Component Missing; Component Missing

    IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING THE RESUSCITATION OF A PATIENT, THE BROSELOW, INTUBATION MOD, WHITE, 2PK WAS CRACKED BY AN ER STAFF> UPON INSPECTION THE DEVICE HAD A MISSING MALE END TO ATTACH THE WALL SUCTION TO THE NG. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT BUT HAD A DELAY IN DECOMPRESSION BECAUSE OF LOOKING FOR A REPLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15916755 ↗

Other Emergency response safety kit devices

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Sources and updates

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