NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET BL+A217Y/V806-NIJRecalls & reported problems
Nipro Medical Corporation · Blood Tubing Set for B Braun Dialog · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383790011884), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Unintended Loss of Vascular Access2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break
CUSTOMER STATES THAT AT THE END OF TREATMENT, UPON DISCONNECTION OF THE BLOODLINE, THE CONNECTION WAS SO TIGHT THAT A MALE INDIVIDUAL HAD TO APPLY ADDED PRESSURE TO DISCONNECT THE BLOOD SET FROM THE CATHETER. THE CATHETER LUER BROKE UPON DISCONNECTION. 3 TOTAL INCIDENTS. THIS RESULTED IN HOSPITAL ADMISSIONS FOR PLACEMENT OF NEW CATHETERS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25443666 ↗InjuryJun 9, 2026Break
CUSTOMER STATES THAT AT THE END OF TREATMENT, UPON DISCONNECTION OF THE BLOODLINE, THE CONNECTION WAS SO TIGHT THAT A MALE INDIVIDUAL HAD TO APPLY ADDED PRESSURE TO DISCONNECT THE BLOOD SET FROM THE CATHETER. THE CATHETER LUER BROKE UPON DISCONNECTION. 2 TOTAL INCIDENTS. THIS RESULTED IN HOSPITAL ADMISSIONS FOR PLACEMENT OF NEW CATHETERS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25443459 ↗
Other SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE devices
- Hemodialysis Bloodlines SL-2010M2096B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve3 recalls3 deaths1,000 reports
- Hemodialysis Bloodlines SL-2010M2096AB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death483 reports
- Hemodialysis Bloodlines SL-2000M2095DAB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death214 reports
- CombiSet 03-2722-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE8 deaths311 reports
- Hemodialysis Bloodlines SL-2000M2095B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall219 reports
- CombiSet 03-2522-1Fresenius Medical Care Holdings, Inc. · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 recall214 reports
- Cartridge Blood Set 101025Gambro Renal Products, S.A. de C.V. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE3 recalls80 reports
- Hemodialysis Bloodlines SL-2000M2095DB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall158 reports
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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