McKesson 26559Recalls & reported problems
Mckesson Medical-Surgical Inc. · NEEDLE, SAFETY PREVENT M 25GX1 · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10612479201382), received between Sep 30, 2019 and Aug 20, 2021 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Device Contamination with Chemical or Other Material2
- Fail-Safe Did Not Operate2
- Fail-Safe Problem2
- Contamination1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
- Needle Stick/Puncture2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHEN ADMINISTRATING A VACCINE TO A CHILD, THE NEEDLE CAME OUT OF THE SAFETY PART AS SHE WAS PULLING THE NEEDLE OUT AFTER ADMINISTERING THE VACCINE. IT WAS ABOUT ¾ OF THE WAY OUT WHEN THE NEEDLE CAME OFF AND SHE WAS EASILY ABLE TO PULL THE NEEDLE OUT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE VACCINE WAS GIVEN TO A (B)(6) YEAR-OLD CHILD. PER CUSTOMER, THE NEEDLE WAS DETACHED AND WAS STILL IN CHILD¿S LEG. THE CUSTOMER WAS ABLE TO REMOVE THE DETACHED NEEDLE WITH NO INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 12350271 ↗InjuryJan 19, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHILE THE NURSE ADMINISTERED PREVNAR 13 VACCINE TO A (B)(6) BABY, THE NURSE FELT UNUSUAL, EXTRA RESISTANCE IN THE NEEDLE. WHEN SHE PUSHED THE MEDICATION, SHE FELT POPPED, THE SYRINGE CAME OFF FROM THE NEEDLE, LEAVING THE NEEDLE IN THE BABY'S SKIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE NEEDLE ITSELF WAS DETACHED FROM THE LUER OF THE SYRINGE WHEN THE NURSE PUSHED THE VACCINE IN. SHE FELT UNUSUAL RESISTANCE AS SHE PUSHED IN AND THE PRESSURE SEPARATED THE SYRINGE AND THE NEEDLE IMMEDIATELY. THE NEEDLE WAS LEFT ON THE BABY AS THE SYRINGE CAME OFF FROM THE NEEDLE. THE SYRINGE USED WAS A PREVNAR13 VACCINE (0.5 ML PREFILL SYRINGE). THE CUSTOMER FURTHER STATED THAT AS THE NURSE PUSHED MEDICATION INTO THE PATIENT, THE SYRINGE AND THE NEEDLE SEPARATED, ALL THE CONTENT FROM THE SYRINGE CAME OUT ON THE BED. THE NEEDLE WAS TAKEN OUT IMMEDIATELY FROM THE LEFT VASTUS LATERALIS BY THE NURSE.
Patient problems: Foreign Body In Patient
MAUDE report 11195430 ↗MalfunctionNov 17, 2020Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED: OFTEN TIMES DURING USE, WHEN THE SAFETY PART IS SLID DOWN OVER THE NEEDLE THE NEEDLE IS GOING THROUGH THE SAFETY PART OF THE NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10852762 ↗MalfunctionOct 28, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THE NEEDLE WAS FLIMSY AND PROTRUDED THROUGH THE PLASTIC OF THE SAFETY SHIELD. THERE WAS NO HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750906 ↗MalfunctionOct 28, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THE NEEDLE WAS FLIMSY AND PROTRUDED THROUGH THE PLASTIC OF THE SAFETY SHIELD. A NEEDLE STICK OCCURRED AS A RESULT OF THE ISSUE. THE NURSE WHO SUSTAINED THE NEEDLE STICK SOUGHT TREATMENT INITIALLY. THE SOURCE PATIENT WAS TESTED AND NEGATIVE.
Patient problems: Needle Stick/Puncture
MAUDE report 10750594 ↗MalfunctionAug 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CUSTOMER REPORTS: THE NEEDLES HAVE PLASTIC PARTICLES INSIDE THE NEEDLE SHEATH AS WELL AS ON THE NEEDLES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10453801 ↗MalfunctionJan 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED: UPON OPENING THE PRODUCT, CONTAMINATION WAS OBSERVED ON THE NEEDLE.
Patient problems: No Patient Involvement
MAUDE report 9581830 ↗MalfunctionJan 10, 2020Contamination
WENT TO USE AN UNOPENED MCKESSON BRAND PREVENT M SAFETY NEEDLE 25GX 1", LOT # 922693, EXP 6/30/24 AND FOUND THAT THE HUB OF THE NEEDLE HAD A GREEN SUBSTANCE ON IT AND IT DID NOT APPEAR STERILE OR APPROPRIATE FOR USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9574633 ↗InjurySep 30, 2019Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER STATES THAT WHEN HE MOVED THE SAFETY GUARD IN POSITION, THE PLASTIC SHIFTED EXPOSING THE NEEDLE AND THE NEEDLE SCRATCHED THE TOP OF HIS MIDDLE FINGER.
Patient problems: Needle Stick/Puncture
MAUDE report 9134784 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.