Cook G04431Recalls & reported problems
Cook Incorporated · Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months) · 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 00827002044319), received between Dec 17, 2018 and Jun 25, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Material Separation1
- Use of Device Problem1
Patient problems
- Dehydration1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED SINCE THE SUBMISSION OF THE LAST REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12068148 ↗MalfunctionDec 17, 2018Difficult to Insert
THE CUSTOMER WAS UNABLE TO GAIN IV ACCESS FOR A DEHYDRATED INFANT. IT WAS REPORTED THAT THEY HAD 3 INTRAOSSEOUS NEEDLE WOULD NOT PENETRATE PATIENT¿S BONE (1 FROM LOT 4477456 THIS MFR AND 2 FROM RELATED MFR #1820334-2018-03827) . THE PATIENT WAS STABILIZED WITH OTHER MEANS AND FORCED FLUIDS. IT WAS FURTHER REPORTED THAT THE PATIENT "PERKED UP" AND THAT THE OUTCOME WAS FAVORABLE AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO OTHER INFORMATION WAS MADE AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8171166 ↗MalfunctionDec 17, 2018Use of Device Problem
THE CUSTOMER WAS UNABLE TO GAIN IV ACCESS FOR A DEHYDRATED INFANT. IT WAS REPORTED THAT THEY HAD 3 INTRAOSSEOUS NEEDLE WOULD NOT PENETRATE PATIENT¿S BONE (2 FROM LOT 4100856 THIS MFR # AND 1 FROM RELATED MFR# 1820334-2018-03828) . THE PATIENT WAS STABILIZED WITH OTHER MEANS AND FORCED FLUIDS. IT WAS FURTHER REPORTED THAT THE PATIENT "PERKED UP" AND THAT THE OUTCOME WAS FAVORABLE AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO OTHER INFORMATION WAS MADE AVAILABLE.
Patient problems: Dehydration
MAUDE report 8171020 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.