NA CHI2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403088872), received between Oct 24, 2024 and Oct 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER IS USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS MATERIAL#CHI2015, LOT#0001535280. WHEN WAS ISSUE DETECTED? - PRIOR TO USE. CUSTOMER RESPONSE ON OCT 16, 2024. WHAT WAS THE IMPACT TO THE PATIENT? IMPACT TO PATIENT WOULD BE THE POTENTIAL FOR HARM. NEEDLE PLACEMENT IS VERY SPECIFIC AND DUE TO THE FORCE REQUIRED TO ATTACH A SYRINGE OR EXTENSION SET, THE POTENTIAL FOR INTERNAL BODY SYSTEM INJURY IS SIGNIFICANT. HOW WAS THE ISSUE RESOLVED? ORDERING A DIFFERENT NEEDLE THAT DOES NOT HAVE A SQUARE HUB FROM A DIFFERENT MANUFACTURER. WAS THE DEFECTIVE PRODUCT USED ON THE PATIENT? YES, MULTIPLE USES FROM MULTIPLE LOTS WITH NOTED DIFFICULTY BY PROVIDERS WITH LEAKING OF HUB AND STRAIN WITH CONNECTION TO SYRINGE/EXTENSION SET. IS THERE A PHYSICAL SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? YES, THIS ISSUE HAS BEEN DEMONSTRATED TO REPRESENTATIVE AND REMAINING STOCK HAS BEEN PULLED FROM PROCEDURE SPACE. CUSTOMER RESPONSE 1 ON OCT 18, 2024. UNFORTUNATELY, I CAN'T GIVE YO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527380 ↗
• MalfunctionOct 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER IS USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS MATERIAL#CHI2015 LOT# 0001535280 WHEN WAS ISSUE DETECTED? - PRIOR TO USE CUSTOMER RESPONSE ON OCT 16, 2024 WHAT WAS THE IMPACT TO THE PATIENT? IMPACT TO PATIENT WOULD BE THE POTENTIAL FOR HARM. NEEDLE PLACEMENT IS VERY SPECIFIC AND DUE TO THE FORCE REQUIRED TO ATTACH A SYRINGE OR EXTENSION SET, THE POTENTIAL FOR INTERNAL BODY SYSTEM INJURY IS SIGNIFICANT. HOW WAS THE ISSUE RESOLVED? ORDERING A DIFFERENT NEEDLE THAT DOES NOT HAVE A SQUARE HUB FROM A DIFFERENT MANUFACTURER. WAS THE DEFECTIVE PRODUCT USED ON THE PATIENT? YES, MULTIPLE USES FROM MULTIPLE LOTS WITH NOTED DIFFICULTY BY PROVIDERS WITH LEAKING OF HUB AND STRAIN WITH CONNECTION TO SYRINGE/EXTENSION SET IS THERE A PHYSICAL SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? YES, THIS ISSUE HAS BEEN DEMONSTRATED TO REPRESENTATIVE AND REMAINING STOCK HAS BEEN PULLED FROM PROCEDURE SPACE CUSTOMER RESPONSE 1 ON OCT 18, 2024 UNFORTUNATELY, I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525978 ↗
• MalfunctionOct 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER IS USING CHI2015 AND WHEN HOOKING UP EXTENSION TUBING IT DOESN'T LOCK ONTO THE SET AND LEAKS. MATERIAL#CHI2015, LOT#0001535280. WHEN WAS ISSUE DETECTED? - PRIOR TO USE. CUSTOMER RESPONSE ON (B)(6) 2024. WHAT WAS THE IMPACT TO THE PATIENT? IMPACT TO PATIENT WOULD BE THE POTENTIAL FOR HARM. NEEDLE PLACEMENT IS VERY SPECIFIC AND DUE TO THE FORCE REQUIRED TO ATTACH A SYRINGE OR EXTENSION SET, THE POTENTIAL FOR INTERNAL BODY SYSTEM INJURY IS SIGNIFICANT. HOW WAS THE ISSUE RESOLVED? ORDERING A DIFFERENT NEEDLE THAT DOES NOT HAVE A SQUARE HUB FROM A DIFFERENT MANUFACTURER. WAS THE DEFECTIVE PRODUCT USED ON THE PATIENT? YES, MULTIPLE USES FROM MULTIPLE LOTS WITH NOTED DIFFICULTY BY PROVIDERS WITH LEAKING OF HUB AND STRAIN WITH CONNECTION TO SYRINGE/EXTENSION SET. IS THERE A PHYSICAL SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? YES, THIS ISSUE HAS BEEN DEMONSTRATED TO REPRESENTATIVE AND REMAINING STOCK HAS BEEN PULLED FROM PROCEDURE SPACE. CUSTOMER RESPONSE 1 ON (B)(6) 2024. UNFORTUNATELY, I CAN'T GIVE YOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523486 ↗