Cook G10050Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Set Neff Access Set with Nitinol Wire Guide Ultrathane · Class U · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002100503), received between Feb 18, 2020 and Jun 11, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging3
- Device Contaminated During Manufacture or Shipping2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE PIECE OF FOREIGN MATTER WAS IDENTIFIED WITHIN THE SEALED PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET DURING AN INCOMING INSPECTION AT THE INTERNATIONAL DISTRIBUTOR. A PHOTOGRAPH PROVIDED BY THE CUSTOMER CONFIRMS THE PRESENCE OF A HAIR-LIKE FIBER WITHIN THE PACKAGE. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. NO HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185417 ↗MalfunctionMar 31, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET WAS PERFORATED. THE FAILURE WAS DISCOVERED BY THE DISTRIBUTOR UPON RECEIPT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13966425 ↗MalfunctionJan 27, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 11238733 ↗MalfunctionJan 27, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 11238663 ↗MalfunctionAug 20, 2020Material Separation; Material Separation
CLARIFICATION FROM THE CUSTOMER STATED THE DAMAGE WAS NOTED PRIOR TO USE. IT WAS THE .018" WIRE THAT FRACTURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10434564 ↗MalfunctionFeb 18, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9720275 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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