SafeDAY™ 352901Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964293771), received between Nov 7, 2017 and Mar 10, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY. DESCRIPTION: WHEN IT WAS ATTACHED TO THE IV CATHETER, IT WOULD LEAK BLOOD AT THE BASE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520231 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: WHEN IT WAS ATTACHED TO THE IV CATHETER, IT WOULD LEAK BLOOD AT THE BASE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520226 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451409 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 7: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451402 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 6: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451400 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451385 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451384 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451368 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT CHEMOTHERAPY LEAKED AT THE CONNECTION PORT DURING USE. NO INJURY REPORTED. IT SHOULD BE NOTED THAT TWO OTHER POTENTIAL LOTS WERE PROVIDED. LOT NUMBER 0061734545; EXPIRY DATE 04/30/2023; PRODUCTION DATE 05/27/2020. LOT NUMBER 0061722066; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/03/2020.

  Patient problems: Chemical Exposure

  MAUDE report 10451365 ↗
• MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT AFTER THE IV WAS STARTED ON PATIENT, PATIENT IMMEDIATELY BEGAN TO BLEED FROM IV AND UPON FURTHER INSPECTION IT WAS NOTED THAT THE BLUE SAFEDAY LUER LOCK WAS NOT "ATTACHED" TO THE IV TUBING AT ALL. IT WAS JUST "SITTING IN THERE". IV WAS IMMEDIATELY STOPPED AND THE EXTENSION SET CHANGED. BLOOD LOSS APPROXIMATELY 30CC. NO MEDICATION LOST. NO FURTHER INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 8382311 ↗
• MalfunctionNov 7, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT WHEN THE PATIENT WAS IN PACU, THE LUER ACCESS DEVICE "SHEARED OFF" FROM THE TUBING AND A SMALL AMOUNT OF BLOOD LEAKED OUT. CUSTOMER STATED THAT IT LOOKED LIKE THE TUBING WASN'T CONNECTED. THE PATIENT NO LONGER NEEDED HER IV SO IT WAS DISCONTINUED AT THAT TIME. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008201 ↗