NIPRO DISPOSABLE SYRINGE JD+10L2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383790001014), received between Jun 6, 2019 and Jan 9, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2020Break; Difficult to Remove

  SYRINGE TIP BROKE OFF IN THE VENOUS PORTION OF THE PERMANENT DIALYSIS CATHETER WHILE BEING PREPPED FOR TREATMENT. THE STAFF WAS UNABLE TO REMOVE THE SYRINGE TIP AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR REMOVAL AND REPLACEMENT OF THE PERMANENT DIALYSIS CATHETER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569361 ↗
• MalfunctionJun 6, 2019Break; Break

  INCIDENTS OCCURRED IN RANDOM DATES. FIRST INCIDENT OCCURRED ON (B)(6) 2019. ANOTHER INCIDENT WAS NOTED ON (B)(6) 2019. LUER LOCK TIP FOUND BROKEN WITH NEEDLE ATTACHED INSIDE INDIVIDUAL PACKAGING. LUER LOCK TIP OF SYRINGE BROKE OFF IN PATIENT'S CATHETER PRIOR TO TREATMENT, STAFF HAD TO REMOVE BROKEN PIECE FROM THE PATIENT'S CATHETER. LUER LOCK TIP OF SYRINGE BROKE IN PATIENT'S FISTULA NEEDLE LINE AFTER COMPLETION OF TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676990 ↗
• MalfunctionJun 6, 2019Break; Break

  THE SYRINGE WAS CONNECTED TO THE AVF NEEDLE TUBING AND HEPARIN WAS FLUSHED INTO THE AVF NEEDLE TUBING, THE LUER LOCK TIP OF THE SYRINGE BREAKS OFF INTO THE AVF NEEDLE TUBING. AFTER THIS HAPPENED THE STAFF REMOVED THE AVF NEEDLE FROM THE PATIENT'S ACCESS, RE-CANNULATED WITH A NEW AVF NEEDLE IN ORDER TO COMPLETE TREATMENT. EXACT DATE OF OCCURRENCE WAS UNKNOWN: ESTIMATED (B)(6) 2019. 3 DIFFERENT LOT NUMBERS INVOLVED: 20170915, 20170815, 20170615.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676938 ↗
• MalfunctionJun 6, 2019Break; Break

  THE TIP OF THE 10CC SYRINGE BROKE OFF INTO/INSIDE THE PATIENT'S FISTULA NEEDLE, PRIOR TO FLUSHING OR ASPIRATING. STAFF REMOVED THE AVF NEEDLE WITH THE BROKEN TIP OF THE SYRINGE, AND PLACED/CANNULATED A NEW FISTULA NEEDLE INTO THE PATIENT'S ACCESS TO CONTINUE TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676861 ↗