NIPRO DISPOSABLE SYRINGE JD+10LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00383790001007), received between Oct 5, 2020 and Jan 4, 2021 — classified as 3 injuries, 2 malfunctions.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2021Material Fragmentation; Material Fragmentation

  LUER LOCK PIECE BROKE OFF WHEN ATTACHING TO THE NEEDLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114682 ↗
• MalfunctionJan 4, 2021Material Fragmentation; Material Fragmentation

  WHEN THE STAFF CONNECTS THE SYRINGE TO THE HEPARIN LINE, AVF NEEDLE LUER LOCK, AND DIALYSIS CATHETER, THE LUER LOCK TIP BREAKS OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114487 ↗
• InjuryDec 2, 2020Break; Break

  SYRINGE TIP BROKE OFF INSIDE OF PATIENT'S DIALYSIS CATHETER, PRIOR TO TREATMENT, PULLING HEPARIN OUT OF THE CATHETER LUMEN. NO INJURIES, MEDICAL INTERVENTIONS OR HOSPITALIZATION WERE REPORTED. THE SYRINGE TIP WAS REMOVED WITH NEEDLE NOSE PLYERS. PATIENT RETURNED TO THEIR REGULAR SCHEDULED TREATMENT WITHOUT FURTHER ISSUES. BRAND OF DIALYSIS CATHETER IS UNKNOWN. CUSTOMER ALSO REPORTED THE SAME ISSUE OCCURRING WITH BLOODLINES(BRAUN STREAMLINE AIRLESS SYSTEM) OCCURRING WITH PATIENTS USING AVF GRAFT/FISTULA. WHILE TWISTING THE NEEDLE INTO THE MEDICATION PORT, AS WELL AS WHILE PLACING A NEEDLE ON THE SYRINGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931898 ↗
• InjuryDec 1, 2020Break; Break

  SYRINGE TIP BROKE OFF INSIDE OF PATIENT'S DIALYSIS CATHETER, PRIOR TO TREATMENT, PULLING HEPARIN OUT OF THE CATHETER LUMEN. NO INJURIES, MEDICAL INTERVENTIONS OR HOSPITALIZATION WERE REPORTED. THE SYRINGE TIP WAS REMOVED WITH NEEDLE NOSE PLYERS. PATIENT RETURNED TO THEIR REGULAR SCHEDULED TREATMENT WITHOUT FURTHER ISSUES. BRAND OF DIALYSIS CATHETER IS UNKNOWN. CUSTOMER ALSO REPORTED THE SAME ISSUE OCCURRING WITH BLOODLINES(BRAUN STREAMLINE AIRLESS SYSTEM) OCCURRING WITH PATIENTS USING AVF GRAFT/FISTULA. WHILE TWISTING THE NEEDLE INTO THE MEDICATION PORT, AS WELL AS WHILE PLACING A NEEDLE ON THE SYRINGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10930981 ↗
• InjuryOct 5, 2020Entrapment of Device; Entrapment of Device

  STAFF REMOVED THE TEGO (DAY TO CHANGE THEM) & ATTACHED AN EMPTY / NO NEEDLE 10CC SYRINGE TO WITHDRAW WHAT WAS PRESENTLY IN THE VENOUS LUMEN. STAFF OBTAINED APPROX. 5 CC SOLUTION AND IMMEDIATELY WENT TO PUT THE NEW TEGO ON TO THE VENOUS LUMEN. AT THAT TIME THE STAFF NOTICED THERE WAS SOMETHING INSIDE THE LUMEN THAT WAS PREVENTING FROM ATTACHING THE NEW TEGO. STAFF ATTEMPTED FOR 20 MIN, TO GET THIS PLASTIC PIECE OUT OF THE VENOUS LUMEN. TREATMENT LINES COULD NOT BE ATTACHED TO THE VENOUS LUMEN TO START THE TREATMENT. PATIENT'S PHYSICIAN WAS NOTIFIED. THE PHYSICIAN WENT TO THE CLINIC TO SEE THE SITUATION AND ATTEMPT TO REMOVE THE PLASTIC THAT WAS IN THE VENOUS LUMEN. HE WAS UNSUCCESSFUL. DOCTOR CALLED THE VASCULAR PHYSICIAN TO TELL HIM ABOUT THE SITUATION. THE VASCULAR PHYSICIAN WAS ABLE TO GET THE PLASTIC PIECE OUT OF THE VENOUS LUMEN. ACCORDING TO THE STAFF, THE PATIENT WAS ABLE TO COMPLETE THEIR SCHEDULED TREATMENT. INCIDENT OCCURRED DURING CATHETER PREPARATION FOR TREATMENT, BEFORE TREATMENT STARTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10632314 ↗