JMS SYSLOC MINI AVF NEEDLE SET 864-1500-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08888483005567), received between Jun 19, 2017 and Jan 14, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, ARRIVED TO TREATMENT; PRE-DIALYSIS VS OBTAINED B/P 153/77; PULSE 86; RESP 17; TEMP 97.8. APPROXIMATELY 2 HOURS INTO THE SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT VS OBTAINED WERE: B/P 97/52; PULSE 84. THE ULTRAFILTRATION WAS TURNED OFF AND THE PATIENT'S LEGS WERE ELEVATED. THE MACHINE SUBSEQUENTLY ALARMED VENOUS PRESSURE AND THE BLOOD PUMP STOPPED. THE PATIENT WAS LETHARGIC AND SLOW TO RESPOND VERBALLY WITH THE VENOUS NEEDLE DISLODGED WITH THE TAPE INTACT ON THE WINGS OF THE NEEDLE. BLOOD WAS NOTED TO BE FLOWING DOWN THE INSIDE OF THE CHAIR; A PUDDLE OF BLOOD WAS UNDER THE CHAIR. ESTIMATED BLOOD LOSS (EBL) WAS 1 UNIT. APPROXIMATELY 400 MLS NORMAL SALINE WAS ADMINISTERED. EMS WAS CALLED. UPON DISCHARGE FROM THE FACILITY VIA EMS, PATIENT WAS ORIENTED WITH B/P 102/64; PULSE 118. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 1 UNIT OF PACK RED BLOOD CELLS (PRBCS) WAS INFUSED IN THE ER.

  Patient problems: Blood Loss; Exsanguination; Hypovolemia

  MAUDE report 8243182 ↗
• InjuryJan 14, 2019Backflow; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Backflow; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A HEMODIALYSIS PATIENT, APPROXIMATELY 45 MINUTES INTO A SCHEDULED 3.5 HOUR HEMODIALYSIS TREATMENT, THE VENOUS FISTULA NEEDLE WAS FOUND TO BE LEAKING BLOOD AROUND THE CANNULATION SITE. STAFF REPORTED VENOUS NEEDLE WAS PARTIALLY DISLODGED. THE TAPE WAS INTACT ON THE WINGS OF THE FISTULA NEEDLE AND SECURED TO THE PATIENT. THE PATIENT WAS UNRESPONSIVE TO VERBAL COMMANDS. VS: B/P: 79/39, PULSE: 104. BLOOD WAS PARTIALLY RETURNED VIA THE VENOUS FISTULA NEEDLE. THE VENOUS CANNULATION SITE INFILTRATED AND THE REMAINING BLOOD WAS RETURNED VIA THE ARTERIAL FISTULA NEEDLE. APPROXIMATELY 800 MLS NORMAL SALINE WAS ADMINISTERED. EMS WAS CALLED. UPON DISCHARGE FROM THE FACILITY VIA EMS, B/P WAS 101/69, PULSE 100, RESP 18. THE PATIENT WAS AWAKE AND ALERT UPON DISCHARGE. HE WAS ADMITTED TO THE HOSPITAL. 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) WERE INFUSED. THE PATIENT RETURNED TO THE FACILITY FOR HEMODIALYSIS ON (B)(6) 2018.

  Patient problems: Blood Loss; Hypovolemia; Loss of consciousness

  MAUDE report 8243170 ↗
• InjuryJun 1, 2018Migration or Expulsion of Device; Device Operates Differently Than Expected; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Operates Differently Than Expected; Device Dislodged or Dislocated

  FROM (B)(6). NURSE REPORTED A SYSLOC MINI LOCK FISTULA SET, WHICH DISENGAGED DURING TREATMENT. PATIENT WAS IN 3RD HOUR OF TREATMENT, AFTER BLOOD PRESSURE CHECK AND BLANKET WAS MOVED, THE SYSLOC MINI BECAME DISENGAGED AND NEEDLE WAS RETRACTED INTO HUB. FROM (B)(6). THREE HOURS INTO A 4 HOUR TX PT C/O FEELING BAD ASKED FOR BP RESULT. PT THEN WANTED BS TAKEN. PT WAS WITH ACUTE BLOOD LOSS FROM NEEDLE THAT HAD RETRACTED INTO SAFETY DEVICE. VENOUS NEEDLE WAS FOUND WITH DRESSING INTACT & BLOOD POURING UP ABOVE VENOUS NEEDLE PT WAS GIVEN NORMAL SALINE & BLOOD PUMP STOPPED PRESSURE HELD. SENT TO ER WITH STABLE BLOOD PRESSURE & ALERT & ORIENTED FOR EVALUATION. ADDITIONAL INFORMATION FROM COMPLAINT REPORT. USER FACILITY EXPLAINED THAT EXTERNAL LOCK ON WING OF SYSLOC MINI CAME UNDONE AFTER BLOOD PRESSURE CHECK. THEY ARE UNCERTAIN EXACTLY HOW, AS THEY DID NOT SEE THE BLANKET SNAG ON THE EXTERNAL LOCK. THEY DO KNOW THAT THE BLANKET WAS COVERING THE ACCESS SITE. NO TUBE ENTANGLEMENT SUSPECTED BUT AFTER BP CHECK AT APPROX. 12:35PM (E.D.T) BLANKET WAS USED BY PATIENT IN ACCESS AREA UNKNOWN IF IT SNAGGED ON ANYTHING AT ALL AS IT DID NOT APPEAR TO DURING CHECKS. PATIENT'S TREATMENT HISTORY FOR HD IS

  Patient problems: Blood Loss

  MAUDE report 7559601 ↗
• InjuryDec 20, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  DATED (B)(6) 2017, JMSS HAD RECEIVED A MEDWATCH DOCUMENT (#(B)(4)) FROM (B)(6) REGARDING THIS INCIDENT. THE OUTPATIENT DIALYSIS FACILITY NOTIFIED US OF BLOOD LOSS DUE TO DISCONNECTION OF FISTULA NEEDLE FROM BLOOD LINE AT LUER CONNECTION. PATIENT CARE TECHNICIAN (PCT) WHOM PERFORMED THE FISTULA NEEDLE CONNECTION FROM FISTULA NEEDLE TO BLOODLINE FOUND NO ABNORMALITIES DURING THE CONNECTION. THERE IS NEITHER LUBRICANT NOR DISINFECTANT USED AT THE CONNECTION PORTION PRIOR TO USE. THERE IS NO VISIBLE OR OBVIOUS DEFECT ON THE AVF SET OBSERVED PRIOR TO USE. FACILITY ADMINISTRATOR (FA) SAID THE PCT WAS NOT FAR AWAY AND THE CONNECTION WAS VISIBLE DURING TREATMENT. PCT DID NOT SEE BLOOD LEAKAGE UNTIL 3.5 HOURS AS PCT'S VIEW TO THE PATIENT WAS FROM THE RIGHT SIDE AND EVERYTHING APPEARED TO BE FINE UNTIL SHE LOOKED CLOSER UNDER THE CHAIR. DURING THE BLOOD LEAKAGE AROUND 3.5 HOURS INTO SCHEDULED 4 HOURS DIALYSIS TREATMENT, THERE WAS NOTHING OUT OF ORDINARY OBSERVED UNTIL APPROXIMATELY 200-300ML OF BLOOD FOUND UNDER PATIENT'S CHAIR. HEMODIALYSIS STAFF REPORTED THE CONNECTION BETWEEN VENOUS BLOODLINE AND VENOUS FISTULA NEEDLE WAS LOOSE. THE TREATMENT WAS STOPPED AFTER THE REMAINING BLOOD IN THE M

  Patient problems: Blood Loss

  MAUDE report 7132853 ↗
• InjuryJun 19, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A HEMODIALYSIS (HD) PATIENT (PT.), ((B)(6), GENDER: MALE), WAS APPROXIMATELY HALF WAY THROUGH A FOUR HOUR TREATMENT (TX), WHEN THE VENOUS NEEDLE BECAME DISCONNECTED FROM THE PT. AND THE PT. LOST "2 TO 3 UNITS OF BLOOD" AND THE BLOOD LOSS WAS ESTIMATED BY THE NURSE AS APPROXIMATELY 750ML. THE MACHINE DID NOT ALARM. THE FACILITY IS LOCATED IN AN ACUTE UNIT AT A HOSPITAL. THE NURSE REPORTED THAT THE PT. WOULD MOVE HIS ARM DURING THE TREATMENT AND HAD TO BE REMINDED TO KEEP IT STRAIGHT. WHILE THE NURSE WAS TENDING TO ANOTHER PT., ANOTHER NURSE NOTICED THE BLOOD COMING FROM THE PT. THE NURSE STATED THAT IT IS ASSUMED THE PT WAS MOVING WHILE THE NURSE WAS TENDING TO OTHER PTS. THE PT. STATED THAT HE DIDN'T FEEL GOOD AND VOMITED A SMALL AMOUNT OF BILE BUT DID NOT LOSE CONSCIOUSNESS. THE NEEDLE SITE WAS COVERED/OCCLUDED, TREATMENT WAS DISCONTINUED, AND THE PT WAS TRANSFERRED IN THE SAME HOSPITAL TO THE ICU WHERE THE PT. WAS TRANSFUSED. THE NURSE REPORTED THAT THE PT. WAS STABLE AFTER THE BLOOD TRANSFUSION WITH 2 PRBC. THE PT HAS RESUMED HIS NORMAL SCHEDULED TREATMENTS. THE NURSE REPORTED THAT THE VENOUS NEEDLE WAS A SYSLOC NEEDLE BUT DID NOT KNOW THE LOT OR ANY OTHER INFORM

  Patient problems: Blood Loss; Confusion/ Disorientation; Vomiting

  MAUDE report 6649411 ↗