JMS WINGEATER A.V.FISTULA NEEDLE SET 820-7005-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08888483005390), received between Apr 4, 2017 and Sep 19, 2024 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Material Fragmentation; Material Fragmentation

  THE DONOR DONATED ON (B)(6) 2024, WITH NO COMPLICATIONS NOTED WHILE HE WAS IN THE PLASMA CENTER. ON (B)(6) 2024, THE DONOR EXPERIENCED ARM DISCOMFORT AROUND THE VENIPUNCTURE (VP) SITE, INITIALLY ATTRIBUTING IT TO A WORKOUT. DESPITE THE DONOR'S USE OF ICE AND HEAT, THE DISCOMFORT DID NOT RESOLVE. THE DONOR VISITED THE ER ON (B)(6) 2024, WHERE HE REPORTED THAT AN X-RAY OF THE LEFT FOREARM REVEALED THAT PART OF THE NEEDLE WAS BENEATH THE VP SITE. THE MSS (PHYSICIAN SUBSTITUTE) ADVISED THE DONOR TO PROVIDE MEDICAL RECORDS AND A BIOLIFE MSS WOULD FOLLOW UP. CURRENTLY, THE DONOR HAS NOT PROVIDED ANY ADDITIONAL INFORMATION OR MEDICAL RECORDS. IMPORTER IS IN COMMUNICATION WITH FACILITY AND TRYING TO GET THE NEEDLE BACK TO MANUFACTURER AFTER IT IS EXTRACTED FROM PATIENT TO ENSURE THIS IS JMS NEEDLE. AT THIS POINT THERE HAS BEEN NO UPDATE FROM PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20263857 ↗
• InjuryApr 11, 2018Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT THE ARTERIAL NEEDLE SEPARATED FROM THE EXTRACORPOREAL SYSTEM MID-HEMODIALYSIS TREATMENT RESULTING IN SIGNIFICANT BLOOD LOSS FROM THE PATIENT. ADDENDUM 21 MAR 2018: PATIENT HAD RECEIVED 500ML NORMAL SALINE AND WAS TRANSPORTED TO THE EMERGENCY ROOM BUT WAS STABLE UPON ARRIVAL. PATIENT WAS MONITORED AND WAS RELEASED AT THE SAME DAY.

  Patient problems: Blood Loss

  MAUDE report 7424160 ↗
• DeathMar 26, 2018Adverse Event Without Identified Device or Use Problem

  THE DONOR CENTER CONTACTED THE DISTRIBUTORS AND IMPORTERS TO INQUIRE IF THERE WERE ANY MANUFACTURING ISSUES FOR DISPOSABLE SOFT-GOODS THEY HAD BEEN USING BECAUSE THERE WAS A FATALITY OF A DONOR. ON (B)(6) 2018, DONOR SUFFERED FROM A SUSPECTED MASSIVE HEART ATTACK AFTER COMPLETED A SUCCESSFUL DONATION A DAY BEFORE ((B)(6) 2018). FATALITY DETAIL WAS SUSPECTED MASSIVE HEART ATTACK (REPORTED BY RELATIVE). DONOR'S DATE OF FIRST DONATION WAS IN (B)(6) 2013. DONOR'S DONATION HISTORY: HE WAS A QUALIFIED DONOR. HE HAD DONATED A TOTAL OF 316 DONATIONS. THERE WAS NO UNUSUAL HISTORY MEDICAL OR VITALS. THERE WAS NO ADVERSE EVENT REPORTED FOR LAST DONATION ON (B)(6) 2018.

  Patient problems: Death

  MAUDE report 7368995 ↗
• DeathApr 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DONOR EXPERIENCED A HEART ATTACK WHICH PROVED FATAL FOLLOWING A DONATION AT THE FACILITY, (B)(6) ON (B)(6) 2017. THE CENTER DID NOT HAVE ANY RECORD FOR THE PRODUCTS/ LOTS USED DURING DONATION HAVING ANY DEFECTS OR NOTED ISSUES. AS PART OF THEIR INVESTIGATION, THE CENTER WAS REQUESTING DOCUMENTATION FROM THE SOFT GOODS MANUFACTURER IF THERE IS ANY ISSUE WITH THE LOTS OF ITEMS USED DURING THE DONOR'S DONATION. THE ACTUAL JMS NEEDLE HAD BEEN DISPOSED.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 6459236 ↗