Porges Coloplast NBI070Recalls & reported problems
Coloplast A/S · BONEE® Needle for bladder injection CH FR 05, 22G, 70 cm, box of 1 · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03600040272930), received between Dec 20, 2021 and Nov 26, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION A HAIR WAS FOUND ON THE INSIDE OF THE UNOPENED PEEL PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656021 ↗MalfunctionJan 18, 2022Unsealed Device Packaging; Contamination /Decontamination Problem; Unsealed Device Packaging; Contamination /Decontamination Problem
ACCORDING TO AVAILABLE INFORMATION, A PHYSICIAN INTENDED TO USE THIS NEEDLE FOR A BOTOX PROCEDURE, HOWEVER, IT WAS THOUGHT THAT THE NEEDLE WAS CONTAMINATED. THE MEDICAL ASSISTANT STATED THAT THE PEEL PACK THAT CONTAINED THE STERILE NEEDLE SEEMED TO BE UNSEALED. PROCEDURE WAS FINISHED WITH ANOTHER NEEDLE, THE ORIGINAL NEEDLE WAS DISCARDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13280678 ↗MalfunctionDec 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
ACCORDING TO THE AVAILABLE INFORMATION, THE INTERNAL PACKAGING OF THE NEEDLE WAS TORN / COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046211 ↗
Other endoscopic injection needle, gastroenterology-urology devices
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- n.a. 27182AKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- n.a. 27030NKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 70cm DIS201Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 35cm DIS199Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology26 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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