MaxGuard MX9171Recalls & reported problems
BD Switzerland Sàrl · Extension set, with 1.2 micron filter and needleless Y-site 41 cm (16 in) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403237669), received between Jun 11, 2018 and Oct 6, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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.
Reports received per month
Recalls naming this device
- 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-1759-2022 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Leak/Splash5
- Complete Blockage1
- Crack1
- Deflation Problem1
- Fluid/Blood Leak1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2023Crack; Leak/Splash; Crack; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: MX9171, BATCH #: 23019378. IT WAS REPORTED BY CUSTOMER AS LEAKING / BREAKING. VERBATIM: LEAKING / BREAKING. HAVE FIVE PRODUCT COMPLAINTS OF THIS SKU AND LOT NUMBER 23019378.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17888481 ↗MalfunctionNov 14, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD EXTENSION SET 1.2-MICRON FILTER WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONCERN WAS THE DEVICE WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15790846 ↗MalfunctionAug 7, 2020Complete Blockage; Restricted Flow rate; Leak/Splash; Complete Blockage; Restricted Flow rate; Leak/Splash
IT WAS REPORTED THAT 16 IN NON-DEHP STANDARD BORE EXT SET LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: MATERIAL NO.: MX9171, BATCH NO.: 20027024, 19115189. IT WAS REPORTED THAT THE MICRON 1.2 FILTER IS "CLOGGING". WE BECAME AWARE OF REPEATED INSTANCES WHERE THE STAFF HAVE SHARED THAT THE ABOVE PRODUCT CONTINUES TO LEAK WHEN USING INTRALIPIDS. LOOKING INTO THE (B)(6) SUPPLY ROOM I FOUND 2 DIFFERENT LOTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10382887 ↗MalfunctionAug 4, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 16 IN NON-DEHP STANDARD BORE EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED NICU CUSTOMER INFO ON (B)(6) 2020. LEAKING OF LIPIDS NOTED FROM BACKSIDE OF FILTER AFTER STARTING INFUSION
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10365246 ↗MalfunctionJul 1, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 16 IN NON-DEHP STANDARD BORE EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SEEMED TO HAVE HAD AN ISSUE WITH DEFECTIVE PRODUCT. THE LOT NUMBER AND THE PACKAGING HAS BEEN DISCARDED. THE SET IS BEING KEPT IN A PLASTIC BAG. NEW INFORMATION RECEIVED: CAN YOU BE MORE SPECIFIC ABOUT THE TWO INCIDENTS YOU ARE TALKING ABOUT IN YOUR EMAIL. I.E. WAS THERE PATIENT INVOLVEMENT? YES- FLUID WAS LEAKING WHILE CONNECTED TO PATIENT¿S CENTRAL LINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10222298 ↗MalfunctionMar 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A FILTER LEAKED WHILE INFUSING LIPIDS INTO A PATIENT.
Patient problems: No Information
MAUDE report 9810942 ↗MalfunctionJun 11, 2018Deflation Problem
SECOND DAY IN A ROW, WHEN PRIMING THE LIPID FILTER, RN WAS UNABLE TO GET ALL THE AIR OUT. RN HAD TO USE MULTIPLE FILTERS TO FIND ONE THAT FINALLY WORKED. RN ASKED AROUND AND OTHERS WERE EXPERIENCING THE SAME ISSUE. THIS EVENT DID NOT REACH THE PATIENT, AS IT OCCURRED WHEN PRIMING THE IV LINE PRIOR TO CHANGING IT OUT. I WAS INFORMED BY THE UNIT SENIOR MANAGER, THAT THE NURSE HAD GONE THROUGH THREE FILTERS BEFORE FINDING ONE THAT WORKED. SENIOR MANAGER ALSO REPORTED THAT THIS HAS BEEN AN ONGOING ISSUE FOR AT LEAST 3 MONTHS. IF YOU WOULD LIKE, YOU CAN CONTACT UNIT MANAGER REGARDING THIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7586332 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.