NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 17GX1-1/4" HC-30WRecalls & reported problems
Nipro Medical Corporation · 17Gx1-1/4" Fixed 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
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00383790000208), received between Nov 9, 2020 and May 11, 2026 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (12 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
- Retraction Problem12
- Fluid/Blood Leak4
- Material Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Hemorrhage/Blood Loss/Bleeding4
- Needle Stick/Puncture2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Fluid/Blood Leak; Material Puncture/Hole
CUSTOMER STATES THERE WAS A HOLE INSIDE OF THE TUBING OF A NEEDLE. DUE TO THE NEEDLE BEING EXPOSED TO BLOOD, IT IS UNAVAILABLE FOR REVIEW. SINCE REPORTING THIS COMPLAINT, THE CUSTOMER HAS CONFIRMED THAT THE HOLE WAS LOCATED DIRECTLY INSIDE OF THE TUBING, ADJACENT TO THE END CAP (NOT THE BEVEL SIDE). THE HOLE PENETRATED THE TUBING, CAUSING BLOOD TO ESCAPE THE TUBING AND DRIP OUT. APPROXIMATELY 200ML OF BLOOD LEAKED. REPLACEMENT FLUID WAS ADMINISTERED TO THE PATIENT WITH 15 MINUTES OF MONITORING THE DONOR. AFTER 15 MINUTES, DONOR LEFT THE FACILITY FEELING WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25143878 ↗InjuryMay 11, 2026Fluid/Blood Leak; Material Puncture/Hole
CUSTOMER STATES THERE WAS A HOLE INSIDE OF THE TUBING OF A NEEDLE. DUE TO THE NEEDLE BEING EXPOSED TO BLOOD, IT IS UNAVAILABLE FOR REVIEW. SINCE REPORTING THIS COMPLAINT, THE CUSTOMER HAS CONFIRMED THAT THE HOLE WAS LOCATED DIRECTLY INSIDE OF THE TUBING, ADJACENT TO THE END CAP (NOT THE BEVEL SIDE). THE HOLE PENETRATED THE TUBING, CAUSING BLOOD TO ESCAPE THE TUBING AND DRIP OUT. APPROXIMATELY 200ML OF BLOOD LEAKED. REPLACEMENT FLUID WAS ADMINISTERED TO THE PATIENT WITH 15 MINUTES OF MONITORING THE DONOR. AFTER 15 MINUTES, DONOR LEFT THE FACILITY FEELING WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25143164 ↗MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTING LEAKAGE OF BLOOD FROM THE CONNECTION POINT BETWEEN THE HARD PLASTIC AND THE TUBING. THERE WAS APPROXIMATELY 200ML OF BLOOD LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22145185 ↗MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTING LEAKAGE OF BLOOD FROM THE CONNECTION POINT BETWEEN THE HARD PLASTIC AND THE TUBING. THERE WAS APPROXIMATELY 200ML OF BLOOD LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22144968 ↗MalfunctionMar 1, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH RESULTING IN A NEEDLE STICK INJURY. STAFF SENT TO PHYSICIAN FOR EVALUATION, ROUTINE LAB WORK OFFERED BUT UNABLE TO CONFIRM IF THE STAFF HAD IT COMPLETED.
Patient problems: Needle Stick/Puncture
MAUDE report 16459713 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH (SAFETY MECHANISM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456480 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH (SAFETY MECHANISM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456065 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH RESULTING IN A NEEDLE STICK INJURY. STAFF SENT TO PHYSICIAN FOR EVALUATION, ROUTINE LAB WORK OFFERED BUT UNABLE TO CONFIRM IF THE STAFF HAD IT COMPLETED.
Patient problems: Needle Stick/Puncture
MAUDE report 16455786 ↗MalfunctionMay 27, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT). NO INJURIES ARE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896853 ↗MalfunctionMay 27, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT). NO INJURIES ARE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896604 ↗MalfunctionMay 10, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT), NO INJURIES ARE REPORTED AT THIS TIME. FACILITY HAS BEEN TRAINED AND HAS BEEN USING THE SAFETOUCH II NEEDLES FOR OVER 5 YEARS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803681 ↗MalfunctionMay 10, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT), NO INJURIES ARE REPORTED AT THIS TIME. FACILITY HAS BEEN TRAINED AND HAS BEEN USING THE SAFETOUCH II NEEDLES FOR OVER 5 YEARS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803653 ↗MalfunctionMar 23, 2021Retraction Problem; Retraction Problem
SEVERAL NEEDLES WOULD NOT RETRACT DURING THEIR DONATION PROCESS, NO INJURIES ARE REPORTED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11559017 ↗MalfunctionMar 23, 2021Retraction Problem; Retraction Problem
SEVERAL NEEDLES WOULD NOT RETRACT DURING THEIR DONATION PROCESS, NO INJURIES ARE REPORTED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11559009 ↗MalfunctionNov 9, 2020Retraction Problem; Retraction Problem
WE RECEIVED A COMPLAINT FROM OUR CUSTOMER STATING THEY RECENTLY (AUGUST 2020) HEARD FROM MULTIPLE CUSTOMERS STATING THE SAFETY DEVICE WILL NOT RELEASE LEAVING THE NEEDLE EXPOSED. THEY ARE NOT SURE HOW MANY OF THESE NEEDLES WERE DEFECTIVE BECAUSE SOME STAFF MEMBERS DID NOT REPORT IT, HOWEVER, ABOUT 10 ON THE INITIAL DATE OF INCIDENT. THERE WERE NO INJURIES, BUT WE PULLED THE NEEDLES FROM PRODUCTION TO PREVENT ANY, AS WELL. STAFF COULD NOT PINCH THE SAFETY DEVICE OR RETRACT THE NEEDLE. THE SAFETY WOULD NOT DISENGAGE, THE NEEDLES HAD TO BE REMOVED WITHOUT PULLING THEM BACK INTO THE SAFETY SHEATH. EXACT DATE OF OCCURRENCE IS UNKNOWN. ACTUAL USED SAMPLES WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10809559 ↗MalfunctionNov 9, 2020Retraction Problem; Retraction Problem
WE RECEIVED A COMPLAINT FROM OUR CUSTOMER STATING THEY RECENTLY ((B)(6) 2020) HEARD FROM MULTIPLE CUSTOMERS STATING THE SAFETY DEVICE WILL NOT RELEASE LEAVING THE NEEDLE EXPOSED. THEY ARE NOT SURE HOW MANY OF THESE NEEDLES WERE DEFECTIVE BECAUSE SOME STAFF MEMBERS DID NOT REPORT IT, HOWEVER, ABOUT 10 ON THE INITIAL DATE OF INCIDENT. THERE WERE NO INJURIES, BUT WE PULLED THE NEEDLES FROM PRODUCTION TO PREVENT ANY, AS WELL. STAFF COULD NOT PINCH THE SAFETY DEVICE, OR RETRACT THE NEEDLE. THE SAFETY WOULD NOT DISENGAGE, THE NEEDLES HAD TO BE REMOVED WITHOUT PULLING THEM BACK INTO THE SAFETY SHEATH. EXACT DATE OF OCCURRENCE IS UNKNOWN. ACTUAL USED SAMPLES WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10809399 ↗
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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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