McKesson 16-N3005Recalls & reported problems
Mckesson Medical-Surgical Inc. · Needle, Hypodermic TW, 30GX 1/2 · Class 2
Quick summary
This is a McKesson hypodermic needle. Reports mostly mention needles breaking, clogging, rough or rusty residue, or detaching from their base. There are 41 reports with no deaths, 3 injuries, and 38 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10612479207384), received between Dec 23, 2022 and Feb 5, 2026 — classified as 3 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information13
- Partial Blockage5
- Break4
- Complete Blockage4
- Compatibility Problem2
- Contamination /Decontamination Problem2
- Detachment of Device or Device Component2
- Improper or Incorrect Procedure or Method2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Needle Stick/Puncture5
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Sharp Edges
IT WAS REPORTED BY THE CUSTOMER THAT DOCTORS HAVE DIFFICULTY WITH THE INSERTION FOR INTRAVITREAL (EYE) INJECTIONS. THE DOCTOR TOOK A CLOSER LOOK AT THE NEEDLE UNDER A MICROSCOPE IN WHICH HE DISCOVERED THE NEEDLES WERE RIDGED AND BARBED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269300 ↗InjuryDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHILE THE FACILITY WAS ADMINISTERING A DENTAL BLOCK, THE NEEDLE DETACHED FROM ITS BASE AND BECAME LODGED IN THE PATIENT'S GUM.
Patient problems: Foreign Body In Patient
MAUDE report 23889682 ↗MalfunctionAug 22, 2025Break; Break
THE NEEDLE POINT OF THE NEEDLE IS EASY TO BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871930 ↗MalfunctionMay 12, 2025Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE NEEDLES WERE NOT ALLOWING THE MEDICATION TO BE PUSHED THROUGH. WHILE THE MEDICATION COULD BE DRAWN UP, IT COULDN'T BE EXPELLED, SUGGESTING THAT THE NEEDLE WAS CLOGGED. THERE WERE NO ISSUES WITH THE SYRINGES USED IN CONJUNCTION WITH THE NEEDLES. NO PATIENT INJURIES WERE SUSTAINED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004157 ↗InjuryMar 27, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED BY THE CUSTOMER THAT A MEDICAL ASSISTANT WAS ACCIDENTALLY STUCK WITH A CONTAMINATED NEEDLE DURING A PROCEDURE. DESPITE USING THE CORRECT CAPPING TECHNIQUE, THE NEEDLE MANAGED TO PIERCE THROUGH ITS CAP. THE CUSTOMER CONFIRMED THAT THIS IS THE ONLY INCIDENT, NO MEDICAL ATTENTION WAS PROVIDED FOR THE MEDICAL ASSISTANT.
Patient problems: Needle Stick/Puncture
MAUDE report 21707640 ↗MalfunctionNov 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT THERE APPEARS TO BE A ROUGH/RUSTY RESIDUE ON THE BEVEL SECTION OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20649617 ↗MalfunctionOct 17, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE CUSTOMER THAT THAT THERE APPEARS TO BE A ROUGH/RUSTY RESIDUE ON THE BEVEL SECTION OF NUMEROUS NEEDLES. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472454 ↗MalfunctionSep 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE NEEDLES ARE DULL. THE CUSTOMER ORDERED THE PRODUCT TWICE, AND THEY EXPERIENCED THE SAME ISSUE ON BOTH OF THEIR ORDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20329574 ↗MalfunctionSep 10, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DETACHMENT/CRACKING/LEAKAGE ON THREE OCCASIONS WHEN REMOVING THE CAP FROM THE NEEDLE FOR INJECTION. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181283 ↗MalfunctionSep 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE NEEDLE TIPS ARE BROKEN. THE CUSTOMER RESPONSES TO THE PROBING QUESTIONS ON 23 AUG 2024 INDICATE THAT THE CUSTOMER WAS HAVING TROUBLE GETTING THE NEEDLES TO REMAIN ATTACHED TO THE SYRINGE. WHEN REMOVING THE CAP FROM THE NEEDLE FOR INJECTION, THE NEEDLE WOULD DETACH FROM THE SYRINGE. THE ACTUAL METAL NEEDLE WAS NOT BROKEN, BUT THE YELLOW PLASTIC OF ONE NEEDLE WAS CRACKED ALL THE WAY DOWN. THERE'S NO PATIENT INJURY, HOWEVER, THERE WAS CONTENT LEAKAGE IN THREE TIRZEPATIDE SHOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164758 ↗MalfunctionSep 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMED THAT THE NEEDLE BROKE DURING THE BIOPSY, THE NEEDLE COMPLETELY BROKE OFF THE HUB AND REMAINED IN THE PATIENT. HOWEVER, NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20115801 ↗MalfunctionAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE DOCTOR CLAIMS THAT WHEN INJECTING, THEY FEEL RESISTANCE AND IT REALLY HURTS THE PATIENT. UPON EXAMINING THE NEEDLE CLOSELY, IT WAS NOTED THAT THE VERY TIP OF THE NEEDLE IS BENT. THIS WAS NOT NOTICED UNTIL THE INJECTION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082278 ↗MalfunctionAug 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WE ARE HAVING AN ISSUE WITH INJECTING. NO LIQUID IS COMING OUT. THE CUSTOMER REPORTED THE SECOND BATCH CJCC12-03 ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19901173 ↗MalfunctionJul 23, 2024Partial Blockage; Partial Blockage
IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE EXPERIENCING ISSUES WITH NO LIQUID COMING OUT OF THE NEEDLES DURING INJECTIONS. THIS WAS REPORTED TO HAVE OCCURRED NUMEROUS TIMES WITH TWO DIFFERENT LOT NUMBERS. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806329 ↗MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER FEEDBACK: WE ARE HAVING AN ISSUE WITH INJECTING. NO LIQUID IS COMING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19786271 ↗MalfunctionJul 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER CLAIMS THAT THE NEEDLES ARE POKING THROUGH CAPS.
Patient problems: Needle Stick/Puncture
MAUDE report 19709398 ↗MalfunctionJul 10, 2024Complete Blockage; Complete Blockage
THE CUSTOMER CLAIMS THAT ABOUT 50 NEEDLES FROM THEIR ORDER HAVE BEEN CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19709367 ↗MalfunctionJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE PRODUCT IS SLIPPING AND LEAKING FLUID WHEN IT IS TIME TO INJECT. THE NEEDLE DOESN'T LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19687256 ↗MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMED THAT THE FLUID/RX DOESN'T GO THROUGH SYRINGE/NEEDLE PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639994 ↗MalfunctionJun 26, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED BY THE CUSTOMER THAT ON FOUR OCCASIONS, THE PRODUCT IS SLIPPING AND LEAKING FLUID WHEN IT IS TIME TO INJECT. THE NEEDLE DOES NOT LOCK. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19615038 ↗MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT DURING A NUMBING PROCEDURE. THE NEEDLE CAME OUT OF THE PLASTIC HUB AS THE NURSE PRACTITIONER WAS RETRACTING THE NEEDLE AFTER THE PROCEDURE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS REPORTED ISSUE.
Patient problems: Needle Stick/Puncture
MAUDE report 19613496 ↗MalfunctionJun 25, 2024Partial Blockage; Partial Blockage
IT WAS REPORTED BY THE CUSTOMER THAT THE FLUID/PRESCRIPTION DRUG DOESN'T GO THROUGH THE SYRINGE/NEEDLE PROPERLY. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19603746 ↗InjuryJun 21, 2024Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER THAT A CONTAMINATED NEEDLE PENETRATED THE CAP RESULTING IN A NEEDLE STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 19587671 ↗MalfunctionMay 20, 2024Partial Blockage; Partial Blockage
THE CUSTOMER CLAIMS THAT THE NEEDLES ARE NOT DISPENSING MEDICATION PROPERLY, THE NEEDLES SEEMED TO BE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349111 ↗MalfunctionMay 17, 2024Partial Blockage; Partial Blockage
IT WAS REPORTED BY THE CUSTOMER THAT ON APPROXIMATELY 30 OCCASIONS, THE NEEDLES DID NOT DISPENSE MEDICATION PROPERLY AND APPEARED TO BE CLOGGED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19340412 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.