NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 16GX1-1/4" HTC-30WRecalls & reported problems
Nipro Medical Corporation · 16Gx1-1/4" Rotating Hub 11" Tubing · Class 2
All models of NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383790000154), received between May 8, 2020 and May 8, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Pain2
- Bruise/Contusion1
- Post Operative Wound Infection1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2020Break; Detachment of Device or Device Component
AFTER COMPLETION OF DIALYSIS TREATMENT, THE SMALL "O" RING BETWEEN THE NEEDLE AND THE WINGS, BROKE OFF DURING NEEDLE REMOVAL. STAFF DID NOT NOTICE AND THE PATIENT'S ACCESS WAS COVERED WITH A BANDAID AND TAPED. ON THE PATIENT'S NEXT SCHEDULED TREATMENT, STAFF REMOVED THE TAPE AND BANDAID AND FOUND AN INDENT / WOUND ON THE PATIENT'S ACCESS. PATIENT COMPLAINED OF PAIN. STAFF FOUND THE SMALL "O" RING STUCK ON THE BANDAID THAT WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain; Post Operative Wound Infection
MAUDE report 10040642 ↗InjuryMay 8, 2020Break; Material Separation; Break; Material Separation
AFTER COMPLETION OF DIALYSIS TREATMENT, THE SMALL "O" RING BETWEEN THE NEEDLE AND THE WINGS, BROKE OFF DURING NEEDLE REMOVAL. STAFF DID NOT NOTICE AND THE PATIENT'S ACCESS WAS COVERED WITH A BANDAID AND TAPED. ON THE PATIENT'S NEXT SCHEDULED TREATMENT, STAFF REMOVED THE TAPE AND BANDAID AND FOUND AN INDENT / WOUND ON THE PATIENT'S ACCESS. PATIENT COMPLAINED OF PAIN. STAFF FOUND THE SMALL "O" RING STUCK ON THE BANDAID THAT WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Bruise/Contusion; Pain; Skin Tears
MAUDE report 10040533 ↗
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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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