NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER 15GX1" HTC-30W-D-CAPRecalls & reported problems
Nipro Medical Corporation · DULL FISTULA NEEDLE for Established Access Sites Only 15Gx1" Rotating Hub 12" Tubing · 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 00383790001250), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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
- Tear, Rip or Hole in Device Packaging2
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
RECEIVED EMAIL NOTIFICATION FROM THE FDA WITH MEDWATCH REPORT NUMBER MW5175663, PER 803.22 (B)(2). DETAILS BELOW: IT WAS REPORTED VIA EMAIL THAT A PATIENT DISCOVERED A HOLE IN TUBING OF NEEDLE HUB. RESULTED IN APPROX. 100CC BLOOD LOSS AND DISCONTINUATION OF TREATMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23410221 ↗InjuryOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
RECEIVED EMAIL NOTIFICATION FROM THE FDA WITH MEDWATCH REPORT NUMBER MW5175663 ATTACHED, PER 803.22 (B)(2). DETAILS BELOW: IT WAS REPORTED VIA EMAIL THAT A PATIENT DISCOVERED A HOLE IN TUBING OF NEEDLE HUB. RESULTED IN APPROX. 100CC BLOOD LOSS AND DISCONTINUATION OF TREATMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23410168 ↗
Other Needle, fistula devices
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5002-33Jms Singapore Pte Ltd · Needle, Fistula6 deaths27 reports
- DORA BAIN-A.V.F-009SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula9 reports
- DORA BAIN-A.V.F-001SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula4 reports
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-7005-33Jms Singapore Pte Ltd · Needle, Fistula2 deaths4 reports
- DORA BAIN-A.V.F-009SGBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula1 report
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5003-33Jms Singapore Pte Ltd · Needle, Fistula1 report
- JMS HARMONY A.V.FISTULA NEEDLE SET 827-1500-33Jms Singapore Pte Ltd · Needle, Fistula1 report
- DORA BAIN-A.V.F-001SGBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula1 report
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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