Cardinal Health 1ml 29Gx1/2"Recalls & reported problems
Jiangsu Caina Medical Co.,Ltd · Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. · Class 2
All models of Cardinal Health (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 06971564467476), received between Jun 23, 2024 and Nov 6, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAVE SEEN A SIGNIFICANT UPTICK IN ERROR REPORTS WITH INCORRECT DOSE OF INSULIN GLARGINE AND OTHER SUBCUTANEOUS MEDS THAT ARE PREPARED IN THEIR INPATIENT PHARMACISTS AND TRANSPORTED TO THE NURSING UNIT. FOR EXAMPLE, THEY PREPARE ALL INSULIN GLARGINE DOSES IN PHARMACY AND THE DOSES ARE CHECKED BY THE TECHNICIAN DRAWING UP THE DOSE AND THE PHARMACIST VERIFYING THE DOSE BEFORE THE SYRINGE IS HEAT-SEALED. THE SYRINGE IN THE HEAT-SEALED PLASTIC BAG IS TRANSPORTED BY A TECHNICIAN (EITHER BY HAND OR ON A CART) TO THE NURSING UNIT AND PLACED IN A PLASTIC BIN IN THE REFRIGERATOR. THEN THE NURSE PULLS THE MEDICATION OUT OF THE REFRIGERATOR, REMOVES IT FROM THE HEAT-SEALED BAG (THEY EDUCATE TO CUT OUT WITH SCISSORS, BUT COULD ALSO BE PUSHING OUT), AND THEN IDENTIFIES THE DOSE IS INCORRECT. THEY HAVE SOME INTERNAL OPPORTUNITIES THAT THEY ARE WORKING TO ADDRESS LIKE IMPROVING THEIR DELIVERY PROCESS TO KEEP THE SYRINGES FROM BEING MOVED AND NURSES FROM PUSHING THE PLUNGER. HOWEVER, DUE TO THE INFLUX OF RECENT EVENTS ACROSS THEIR ENTIRE SYSTEM, THEY ARE ALSO CONCERNED THAT THERE MAY BE SOME DEFECT WITH THE SYRINGE THAT MAKES IT LESS STABLE FOR TRANSPORT. THEY PREVIO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20617643 ↗MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER STATED SHE HAD A NEW SHIPMENT ARRIVE TODAY AND TESTED ONE OF THE SYRINGES. WHEN YOU PULL THE ORANGE CAP OFF, THE SAFETY ENGAGES UNLESS YOU ACTUALLY HOLD THE SAFETY DOWN. THEN TO REATTACH THE CAP IF NECESSARY, IT IS VERY DIFFICULT TO PUT BACK ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639987 ↗MalfunctionJun 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAD A NEEDLE STICK INJURY DUE TO THE DIFFICULTY OF GETTING THE CAP OFF/ON. ON (B)(6) 2024 THE CUSTOMER STATED THAT THE NEEDLE STICK WAS A CLEAN STICK, HOWEVER IT HAD BEEN IN THE MEDIATION VIAL. SAMPLE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19591778 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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