JMS HARMONY A.V.FISTULA NEEDLE SET 827-1500-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08888483005475), received between Jul 11, 2017 and Jul 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REGISTERED NURSE REPORTED THAT THE PATIENT PLACED ONLY GAUZE OVER THE NEEDLE SITE, WITHOUT TAPE, AND THE NEEDLE DISLODGED DURING TREATMENT. THE PATIENT ATTEMPTED TO REPOSITION THE NEEDLE BUT WAS UNSUCCESSFUL AND TERMINATED THE TREATMENT. THE PATIENT THEN FAILED TO APPLY PRESSURE TO THE SITE AND CONTINUED TO BLEED. THE PATIENT REQUIRED A SUTURE ON THE SITE IN THE EMERGENCY DEPARTMENT. THE PATIENT LOST OVER AROUND 100ML BLOOD AND THE EXTRACORPOREAL CIRCUIT WAS WASTED. THE NEEDLE FELL OUT AND THE PATIENT DID NOT APPLY PRESSURE ALLOWING FOR ADDITIONAL BLOOD LOSS (100ML ESTIMATED BLOOD LOSS IS 100CC). THE PATIENT DID NOT KNOW WHY HE HAD DONE THIS. HE ATTEMPTED TO RE-INSERT A VENOUS NEEDLE AND WAS UNABLE TO DO SO. HE WENT TO THE EMERGENCY ROOM AND UPON ARRIVAL, HE STATED THAT HE WAS BLEEDING. HE TOLD THE EMERGENCY STAFF THAT HE WAS SUPPOSED TO PUT PRESSURE ON IT. THE PATIENT DID NOT REQUIRE ANY FURTHER TREATMENT IN THE EMERGENCY ROOM THAN THE SUTURE. HE IS DOING WELL NOW. THE NURSE STATED THAT THE PATIENT MIGHT HAVE DONE A LITTLE DAMAGE WHEN HE WAS ATTEMPTING TO PLACE A SECOND VENOUS NEEDLE WHICH LEADS TO AN ABRASION. HENCE, THE PATIENT HAS TO SEEK MEDICAL CARE IN THE EMERGENCY CARE IN T

  Patient problems: Abrasion; Blood Loss

  MAUDE report 6704870 ↗