NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 15GX1" HC-30WRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00383790000062), received between Nov 9, 2020 and May 27, 2021 — classified as 14 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Material Fragmentation; Material Fragmentation

  DURING DIALYSIS TREATMENT THE SMALL CLEAR PLASTIC RING BELOW THE SAFETY, HAD CRACKED AND FELL OFF. TREATMENT WAS COMPLETED AND THE NURSE WENT TO REMOVE THE AVF FISTULA NEEDLE AND NOTED IT WAS SITTING BY THE PATIENTS HAND. NO ISSUE REMOVING THE AVF NEEDLE. NO INJURIES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897958 ↗
• MalfunctionMay 27, 2021Material Fragmentation; Material Fragmentation

  DURING DIALYSIS TREATMENT THE SMALL CLEAR PLASTIC RING BELOW THE SAFETY, HAD CRACKED AND FELL OFF. TREATMENT WAS COMPLETED AND THE NURSE WENT TO REMOVE THE AVF FISTULA NEEDLE AND NOTED IT WAS SITTING BY THE PATIENTS HAND. NO ISSUE REMOVING THE AVF NEEDLE. NO INJURIES OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897875 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346874 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346870 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346854 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346840 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346830 ↗
• MalfunctionFeb 18, 2021Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346819 ↗
• MalfunctionDec 23, 2020Retraction Problem; Retraction Problem

  SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. (3 TOTAL INCIDENTS) THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019 T HE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019 WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070510 ↗
• MalfunctionDec 23, 2020Retraction Problem; Retraction Problem

  SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. (2 TOTAL INCIDENTS) THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019, WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070481 ↗
• MalfunctionDec 18, 2020Retraction Problem; Retraction Problem

  SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019, WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041473 ↗
• MalfunctionDec 18, 2020Retraction Problem; Retraction Problem

  SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019, WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036535 ↗
• MalfunctionNov 9, 2020Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. FURTHER INFORMATION HAS BEEN REQUESTED INCLUDING WHAT THE AFFECTED LOT# IS. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. ADDITIONAL DETAILS 10/22/2020: THE TREATMENT WAS COMPLETED, WITH NO INTERRUPTIONS. NO PATIENT HARM. AT THE END OF THE TREATMENT WHEN STAFF REMOVED THE NEEDLE FROM THE PATIENT ACCESS, THEY WERE UNABLE TO SLIDE THE SAFETY OVER THE NEEDLE: SOME WOULD NOT MOVE AT ALL, MY EXPERIENCE WAS THAT THEY WERE VERY DIFFICULT TO MOVE, CAUSING THE USE OF 2 HANDS, AND DRIPPING BLOOD AND SALINE IN THE PROCESS. EXACT DATE OF OCCURRENCE IS UNKNOWN. EVENT OCCURRED BETWEEN SEPTEMBER AND OCTOBER 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10809100 ↗
• MalfunctionNov 9, 2020Retraction Problem; Retraction Problem

  NURSE MANAGER, REPORTED THAT A SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. FURTHER INFORMATION HAS BEEN REQUESTED INCLUDING WHAT THE AFFECTED LOT# IS. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. ADDITIONAL DETAILS 10/22/2020: THE TREATMENT WAS COMPLETED, WITH NO INTERRUPTIONS. NO PATIENT HARM. AT THE END OF THE TREATMENT WHEN STAFF REMOVED THE NEEDLE FROM THE PATIENT ACCESS, THEY WERE UNABLE TO SLIDE THE SAFETY OVER THE NEEDLE: SOME WOULD NOT MOVE AT ALL, MY EXPERIENCE WAS THAT THEY WERE VERY DIFFICULT TO MOVE, CAUSING THE USE OF 2 HANDS, AND DRIPPING BLOOD AND SALINE IN THE PROCESS. EXACT DATE OF OCCURRENCE IS UNKNOWN. EVENT OCCURRED BETWEEN SEPTEMBER AND OCTOBER 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10808979 ↗