JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5003-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08888483005307), received between Feb 8, 2019 and Feb 8, 2019 — 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.

• InjuryFeb 8, 2019Device Dislodged or Dislocated; Expulsion; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Expulsion; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, (AGE: 69, GENDER: FEMALE; ESTIMATED DRY WEIGHT: 88KG), ARRIVED TO TREATMENT ALERT AND ORIENTED. PRE-DIALYSIS VITAL SIGNS OBTAINED: B/P: 187/62; PULSE 72; RESP 18; TEMP: 98.0. AT 19:59, THE PATIENT WAS OBSERVED WITH ACCESS COVERED AND NO BLEEDING FROM SITE. AT 20:01, APPROXIMATELY 2.5 HOURS INTO SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT DURING THE Q 30 MINUTE VITAL SIGNS CHECK, THE PATIENT WAS NOTED TO BE SLOW TO RESPOND. VS OBTAINED: B/P 47/26; PULSE 64. PATIENT'S VENOUS NEEDLE WAS DISLODGED WITH TAPE INTACT ON THE WINGS OF THE NEEDLE. LARGE AMOUNT OF BLOOD WAS NOTED ON BOTH THE CHAIR AND THE FLOOR. EBL 500ML. THE VENOUS LINE WAS CLAMPED AND PRESSURE APPLIED TO THE VENOUS CANNULATION SITE. NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL NEEDLE. 911 WAS CALLED. AFTER INFUSION OF APPROXIMATELY 1000ML NORMAL SALINE, B/P: 126/53; PULSE 64; PATIENT WAS ALERT AND ORIENTED. UPON DISCHARGE FROM THE FACILITY VIA EMS, THE PATIENT WAS ALERT AND ORIENTED WITH B/P 110/50; PULSE 67; RESP 18. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. THE PATIENT RETURNED TO THE FACILITY FOR HEMODIALYSIS ON (B)(6) 2018.

  Patient problems: Blood Loss; Hypovolemia; Low Blood Pressure/ Hypotension

  MAUDE report 8319395 ↗