DeRoyal 6833Recalls & reported problems
Deroyal Industries, Inc. · Umbilical Cord Clamp · Class 1
- 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 00749756173797), received between Oct 9, 2020 and Aug 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Difficult to Open or Close1
- Mechanical Problem1
- Positioning Failure1
- Unintended Movement1
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.
MalfunctionAug 9, 2024Positioning Failure; Positioning Failure
A USER FACILITY REPORTED, "WHEN OUR NICU RESPONDER WAS WITH A NEW PATIENT PLACING A CORD CLAMP, SHE WAS UNABLE TO GET IT TO STAY LOCKED AND THE CLAMP CONTINUED TO BOUNCE OPEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950661 ↗MalfunctionAug 9, 2024Difficult to Open or Close; Device Dislodged or Dislocated; Difficult to Open or Close; Device Dislodged or Dislocated
A DEROYAL UMBILICAL CORD CLAMP WAS PLACED ON AN INFANT. THE NURSE HEARD A NOISE THAT SOUNDED LIKE THE BABY PASSING GAS, BUT UPON INVESTIGATION REALIZED THAT THE CORD CLAMP HAD POPPED OPEN. WHEN REPORTED HER COWORKERS HAD VOICED THAT THIS HAD HAPPENED PREVIOUSLY, ESPECIALLY WITH HEALTHY THICK CORDS, THAT THE CLAMP WILL NOT STAY CLOSED - WHICH IS CONCERNING AS AN INFANT COULD BLEED OUT FORM AN OPEN CORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950049 ↗MalfunctionOct 9, 2020Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
PHYSICIANS HAVE COMPLAINED THAT THE CLAMP ISN'T STURDY ENOUGH TO HOLD WHEN PLACED ON THE UMBILICAL CORD, WHICH IS CAUSING THE CLAMP TO POP OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10657643 ↗
Other DEVICE, OCCLUSION, UMBILICAL devices
- ETHICON U10TEthicon, LLC · DEVICE, OCCLUSION, UMBILICAL4 reports
- DeRoyal 10-1281Deroyal Industries, Inc. · DEVICE, OCCLUSION, UMBILICAL3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.