Henry Schein 5702587Recalls & reported problems
Henry Schein, Inc. · Safety IV Catheter 22gx1" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10304040151997), received between May 4, 2023 and May 28, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTS THAT WHILE THE PATIENT WAS AT THE CLINIC FOR ANTIOXIDANTE INFUSION ON SUNDAY AT 10:12 THE RN UTILIZED THE HENRY SCHEIN REF 570-2587 LOT 50539/0350, EXPIRATION DATE 2030-06-21 22G SAFETY IV CATHETER TO INSERT CLIENT'S IV TO HIS L-AC. DURING IV INSERTION, THIS RN OBSERVED A FLASH OF BLOOD IN THE TUBING OF THE IV CATHETER. TOURNIQUET WAS REMOVED AND THEN RN ADVANCED THE CATHETER SUCCESSFULLY INTO THE PATIENT'S VEIN. THE PATIENT HAS NO MEDICAL HISTORY AND IS HEALTHY. AS THE RN WAS RETRACTING THE NEEDLE, SHE OBSERVED A DROP OF BLOOD AT THE INSERTION SITE. THE NURSE ATTACHED THE PRIMED EXTENSION SET TO THE CATHETER, ATTEMPTED TO FLUSH, AND SUDDENLY THE PLASTIC CATHETER DISCONNECTED FROM THE TIP OF THE BLUE TRANSLUCENT HUB. UPON ASSESSMENT THERE WAS MILD REDNESS AND NO VISIBLE PLASTIC PRESENT AT INSERTION SITE, BUT STILL PALPABLE IN THE AREA. THE PATIENT WAS INSTRUCTED TO GO TO THE NEARBY HOSPITAL WHERE THEY REMOVED IT SURGICALLY AND STITCHED IT BUT NUMBER OF STITCHES NOT KNOWN. THE PATIENT REPORTED NO COMPLICATIONS AND DOING WELL AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 25324282 ↗InjuryFeb 4, 2026Material Split, Cut or Torn
DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE IT WAS FOUND THAT THE FLUID WAS LEAKING FROM WHERE THE CANNULA CONNECTED TO THE CATHETER. WHEN THEY TOOK THE DRESSING OFF TO FURTHER INVESTIGATE THAT IS WHEN IT WAS REALIZED THE CANNULA WAS DETACHED FROM THE CATHETER AND HAD REMAINED IN THE ARM OF AN 18 YEAR OLD MALE PATIENT. THIS WAS IN THE RIGHT ANTECUBITAL VEIN OF THE PATIENT. THE CANNULA WAS REMOVED BY A VASCULAR SURGEON UNDER LOCAL ANESTHETIC. THE PATIENT HAD TO TRANSFER TO THE EMERGENCY ROOM AND HAVE THE CANNULA REMOVED. THE PATIENT HAD TO RECEIVE STITCHES TO CLOSE THE REMOVAL SITE.
Patient problems: Foreign Body In Patient
MAUDE report 24262556 ↗MalfunctionMay 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUTOMER REPORTED THAT NO PROCEDURE WAS BEING DONE BUT THE PATIENT, A 67 YEAR OLD MALE WAS IN PRE-OP, SCHEDULED FOR AN ENDOSCOPIC PROCEDURE. THE OFFICE FOUND THAT THE IV FLUID WAS LEAING AROUND THE HUB OF THE CATHETER WHEN IT WAS HOOKED UP. THEN THE HUB CAME OFF OF THE PATIENT WITHOUT THE PLASTIC CANULA ATTACHED AND COULD NOT BE LOCATED. THEREFOR RIGHT AFTER THIS WAS REALIZED THE PATIENT WAS SENT TO THE HOSPITAL FOR X-RAYS AND AN ULTRASOUND. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NOTHING BEING FOUND.
Patient problems: Insufficient Information
MAUDE report 16868988 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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