MaxGuard MX9166Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885403237652), received between Nov 29, 2018 and Dec 16, 2022 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1758-2022 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR ONCOLOGY INFUSION CENTER, WE HAVE HAD 3 REPORTS OF FILTERS LEAKING TODAY. IT IS BD MAXGUARD EXTENSION SET WITH 0.2 MICRON FILTER AND NEEDLELESS Y-SITE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997004 ↗
• MalfunctionOct 22, 2020Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED CAUSING UNDERINFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166 BATCH NO: UNKNOWN. IT WAS REPORTED THAT AT CONCLUSION OF DRUG INFUSION AND WHEN DISCONNECTING IV TUBING, FLUID WAS OBSERVED TO BE LEAKING FROM THE FILTER ONTO THE CHAIR AND ONTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722943 ↗
• MalfunctionOct 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO FOLLOW-UP ON THE PRODUCT REPORT BELOW, THERE WAS ANOTHER FILTER LEAK WITH THIS SAME PRODUCT REPORTED TODAY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666674 ↗
• MalfunctionSep 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166 BATCH NO: 20025076. EVENT DESCRIPTION: MAXGUARD EXTENSION SET WITH 0.2 MICRON FILTER AND NEEDLESS Y-SITE LEAKED WHEN CONNECT TO CHEMOTHERAPY. I DID NOT WITNESS LEAK MYSELF. HOWEVER, THE RN STATED THIS HAS HAPPENED PREVIOUSLY SO PACKAGING WAS SAVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570915 ↗
• MalfunctionSep 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166 BATCH NO: 19017181. EVENT DESCRIPTION: APPROXIMATELY 1 HOUR INTO INFUSION WITH IDS SUPPLIED FILTER ATTACHED TO INFUSION TUBING PT NOTICED FILTER LEAKING (SAME SPOT AS 2 WEEKS AGO) FILTER REMOVED AND CHANGED; PT EXTREMITIES CLEANED WITH SOAP AND WATER. INFUSION RESUMED WITH NEW FILTER ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570912 ↗
• MalfunctionSep 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166 BATCH NO: 19017181 IT WAS REPORTED THAT PATIENT NOTICED LEAKING FROM FILTER AND STATED THIS HAPPENED 3 TIMES. EVENT DESCRIPTION: DURING INFUSION OF DARATUMUMAB STUDY DRUG PT NOTICED LEAKING COMING FROM FILTER; INFUSION STOPPED; IDS PHARMACY CALLED AND FILTER REPLACED - SITE CLEANED WITH SOAP AND WATER; INFUSION RESUMED WITH NEW FILTER; PT STATED THIS IS 3RD INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570911 ↗
• MalfunctionOct 29, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE COMING FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN "CIRCLE AREA". IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9250819 ↗
• MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN "CIRCLE AREA". IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247437 ↗
• MalfunctionOct 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN CIRCLE AREA. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241835 ↗
• MalfunctionOct 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN CIRCLE AREA. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241834 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE IS A LEAK COMING FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN "CIRCLE AREA". IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198307 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE IS LEAK COMING FROM THE BACK SIDE OF THE FILTER FROM THE BUILT-IN; "CIRCLE AREA". IT WAS ALSO CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197537 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Information

  MAUDE report 9196931 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET FILTER LEAKED FROM THE "CIRCLE AREA" ON THE BACKSIDE OF THE FILTER. IT WAS STATED; THAT THIS "HAPPENED ALMOST DAILY" WHILE THE PATIENT WAS IN THE PICU AS WELL. THERE WAS NOT PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194861 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A TPN INFUSION THERE WAS A LEAK FROM THE AIR-ELIMINATING FILTER. THERE WERE 2 OCCURRENCES, USING 2 SEPARATE FILTERS, WITH THE SAME LOT NUMBER. THE FILTERED LEAKED FROM THE BACK SIDE OF THE BUILT-IN "CIRCLE AREA". BOTH INCIDENTS INVOLVED THE SAME PATIENT. ON THE FIRST OCCURRENCE, THE FILTER WAS ATTACHED FOR APPROXIMATELY 10 HOURS AND ON THE SECOND OCCURRENCE, IT WAS ATTACHED FOR 6 HOURS. IT WAS CONFIRMED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193888 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Information

  MAUDE report 9193540 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Information

  MAUDE report 9193528 ↗
• MalfunctionOct 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A TPN INFUSION THERE WAS A LEAK FROM THE AIR-ELIMINATING FILTER. THERE WERE 2 OCCURRENCES, USING 2 SEPARATE FILTERS, WITH THE SAME LOT NUMBER. THE FILTERED LEAKED FROM THE BACK SIDE OF THE BUILT-IN "CIRCLE AREA". BOTH INCIDENTS INVOLVED THE SAME PATIENT. ON THE FIRST OCCURRENCE, THE FILTER WAS ATTACHED FOR APPROXIMATELY 10 HOURS AND ON THE SECOND OCCURRENCE, IT WAS ATTACHED FOR 6 HOURS. IT WAS CONFIRMED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177534 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET FILTER WAS FOUND TO HAVE LEAKED FROM THE "CIRCLE AREA" ON THE BACKSIDE OF THE FILTER PRIOR TO THE INITIATION OF A CHEMOTHERAPY INFUSION IN THE PEDIATRIC ONCOLOGY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8907992 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET FILTER WAS FOUND TO HAVE LEAKED FROM THE "CIRCLE AREA" ON THE BACKSIDE OF THE FILTER PRIOR TO THE INITIATION OF A CHEMOTHERAPY INFUSION IN THE PEDIATRIC ONCOLOGY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8907487 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET FILTER WAS FOUND TO HAVE LEAKED FROM THE "CIRCLE AREA" ON THE BACKSIDE OF THE FILTER AFTER THE COMPLETION OF A CHEMOTHERAPY INFUSION IN THE PEDIATRIC ONCOLOGY DEPARTMENT.

  Patient problems: No Information

  MAUDE report 8907426 ↗
• MalfunctionFeb 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE SURGICAL ONCOLOGY DEPARTMENT A LEAK WAS NOTICED ON THE BACK SIDE OF THE FILTER WHERE THERE IS AN INDENTATION. THERE WAS NO REPORT OF HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362742 ↗
• MalfunctionNov 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SET LEAKED FROM THE VENT HOLE ON THE BACK OF THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117361 ↗