Magellan 8881811558Recalls & reported problems
Cardinal Health 200, LLC · Syringe with Hypodermic Safety Needle · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253025378), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fail-Safe Did Not Operate1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2023Break; Fail-Safe Did Not Operate; Break; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THE STAFF REVIEWS OF THE SAFETY NEEDLES HAVE NOT BEEN FAVORABLE. THEY STATED THAT THE SAFETY SHIELD IS NOT USER FRIENDLY AND GETS CAUGHT AND BOTH THE NEEDLE AND SAFETY SHIELD ARE VERY FLIMSY AND BEND EXTREMELY EASILY. WHEN THEY PUSH THE COVERING OVER THE NEEDLE USING THE THUMB, FINGER, AND FLAT SURFACE TECHNIQUES, THEY THINK IT¿S COVERED BUT THEY HAVE TO PUSH HARDER TO GET IT TO SNAP SECURELY. THE SAFETY MECHANISM HAS BENT EXPOSING A BROKEN NEEDLE AND THE NEEDLES HAVE BENT WHEN ADMINISTERING AN INTERMUSCULAR SHOT IN THE DELTOID, WHEN PUTTING ON THE SAFETY, AND WHEN ADMINISTERING AND DRAWING UP PRODUCT. WHEN GIVING MULTIPLE SHOTS ON A CHILD, THEY NEED A SAFETY FEATURE THAT WORKS QUICKLY AND EFFECTIVELY EVERY TIME. THEY HAVE HAD SEVERAL NEEDLE STICKS DUE TO THE SAFETY NOT FULLY ENGAGING AND DON¿T WANT TO PUT THEIR PATIENT¿S SAFETY AT HARM. THE EXACT NUMBER OF CLINICIANS THAT HAVE EXPERIENCED NEEDLE STICKS AND THE DETAILS OF EACH EVENT ARE UNKNOWN BUT PER THE CUSTOMER THE TREATMENT PROTOCOL FOR BBPI WAS FOLLOWED INCLUDING BLOOD WORK, FOLLOW UP BLOOD WORK, POSSIBLE PEP (POST-EXPOSURE PROPHYLAXIS) AND UPDATING TETANUS. THE SPECIFICS OF TREATMENT FOR EACH INCID
Patient problems: Needle Stick/Puncture
MAUDE report 16792094 ↗
Other Needle, Hypodermic, Single Lumen devices
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- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
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- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.