MaxGuard MX9968Recalls & reported problems
BD Switzerland Sàrl · 15 drop administration set, with 2 needleless Y-sites and back check valve 280 cm (110 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885403237805), received between Jul 9, 2019 and Aug 1, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Material Separation4
- Component Missing3
- Backflow1
- Break1
- Complete Blockage1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2025Complete Blockage; Complete Blockage
MalfunctionOct 29, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20563302 ↗MalfunctionNov 28, 2023Component Missing; Component Missing
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS MISSING A COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. THE CUSTOMER SENT IN SAMPLES WITH TWO DIFFERENT LOT NUMBERS: IF THEY ARE REPORTING ONLY 1 LOT NUMBER, THE OTHER LOT NUMBER (23069048) WILL NEED A NEW COMPLAINT BECAUSE THAT SAMPLE DOES NOT HAVE A CLAMP AS WELL. THE NEW COMPLAINT WILL NEED TO CREATED, WITH THE AWARENESS DATE OF (B)(6) 2023, THE DAY I WAS ABLE TO VERIFY THAT MATERIAL MX9968, LOT NUMBER 23069048 WAS MISSING ITS ROLLER CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18218792 ↗MalfunctionOct 31, 2023Component Missing; Component Missing
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS MISSING COMPONENTS. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: REPORTED ISSUE PER CUSTOMER: 4 EACH OF THE TUBING WERE MISSING THE ROLLER CLAMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18039273 ↗MalfunctionOct 16, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: 2 SEPARATE SETS WERE DEFECTIVE, FIRST DID NOT HAVE AN END CAP/PORT THE TUBING JUST ENDED. THE SECOND SET OF TUBING WAS LEAKING FROM ONE OF THE PORTS. PRODUCT SHOULD HAVE NO LEAKS AND HAVE A LUER LOCK MALE PORT AT ONE END OF TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17946809 ↗MalfunctionOct 12, 2023Component Missing; Component Missing
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: MX9968, BATCH #: 23069048 IT WAS REPORTED BY CUSTOMER THAT 2 SEPARATE SETS WERE DEFECTIVE, FIRST DID NOT HAVE AN END CAP/PORT THE TUBING JUST ENDED. THE SECOND SET OF TUBING WAS LEAKING FROM ONE OF THE PORTS. PRODUCT SHOULD HAVE NO LEAKS AND HAVE A LUER LOCK MALE PORT AT ONE END OF TUBING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE REFERENCE: (B)(4). ITEM: MX9968, QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: [email protected]. CUSTOMER DISPOSITION REQUEST: CREDIT. REPORTED ISSUE BELOW: 2 SEPARATE SETS WERE DEFECTIVE, FIRST DID NOT HAVE AN END CAP/PORT THE TUBING JUST ENDED. THE SECOND SET OF TUBING WAS LEAKING FROM ONE OF THE PORTS. PRODUCT SHOULD HAVE NO LEAKS AND HAVE A LUER LOCK MALE PORT AT ONE END OF TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919446 ↗MalfunctionSep 21, 2023Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) LUER LOCK COLLAR BROKE DURING DISCONNECTING AND CAUSED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. P INJURIES OR ADVERSE EVENT: NO REPORTED ISSUE: DISTAL PORT CAUSES STICKING OF 40" IV SECONDARY ROTATING MALE LUER LOCK. UPON ATTEMPTING TO DISCONNECT, LUER LOCK BREAKS AND IF THE PRIMARY LINE IS NOT CLAMPED, ALL FLUIDS RUSH OUT. THIS HAS HAPPENED 3-4 TIMES SO FAR.
Patient problems: Insufficient Information
MAUDE report 17790005 ↗MalfunctionSep 15, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17761217 ↗MalfunctionAug 8, 2023Backflow; Material Separation; Backflow; Material Separation
IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) SEPARATED WHILE IN USE CAUSING LEAKAGE AND BACK FLOW OF BLOOD WITH THE IV. IT WAS REPORTED BY THE INITIAL REPORTER THAT VERBATIM: PER NURSE SHE JUST STARTED A CLIENT'S IV AND WENT TO DRAW UP HER NUTRIENTS. WHEN I CAME BACK AND STARTED IV PUSHING HER NUTRIENTS THROUGH THE PORT CLOSEST TO THE IV FLUIDS, THE TUBING COMPLETELY SNAPPED IN HALF AND IVF WERE FLOWING EVERYWHERE ON THE GROUND AND THE CLIENT'S IV STARTED BACK FLOWING BLOOD IMMEDIATELY. IT MADE A MESS AND WAS VERY INCONVENIENT FOR THE CLIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484121 ↗MalfunctionAug 5, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN APRIL, A PARAMEDIC WENT TO SPIKE A BAG OF IV FLUID AND TUBING (RE# MX9968 LOT# 22019189) JUST SORT OF FELL OUT OF CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174884 ↗MalfunctionAug 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE 110 IN 15 DROP IV ADMINISTRATION SET EXPERIENCED FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING PACKAGE OPENED AND UPON EXAMINATION IT WAS FOUND TO HAVE A YELLOW SUBSTANCE ON THE STERILE PUNCTURE PIECE ABOVE THE DRIP CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264651 ↗MalfunctionMar 3, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT 110 IN 15 DROP IV ADMINISTRATION SET HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9968; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE ARE MULTIPLE INSTANCES WHERE MICROBUBBLES HAVE BEEN OBSERVED IN THE TUBING, RESULTING IN THE STAFF BEING UNABLE TO FLUSH DURING ABLATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11408239 ↗MalfunctionOct 7, 2019Material Separation; Material Separation
IT WAS REPORTED THAT WHILE THE NURSE WAS AT THE PATIENT'S BEDSIDE, THE TUBING BECAME TANGLED. THE NURSE WAS TRYING TO ASSIST PATIENT WHEN TUBING PULLED APART. THERE WERE NO LEAKS AND NO PATIENT HARM.
Patient problems: No Information
MAUDE report 9163782 ↗MalfunctionJul 9, 2019Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE USER WAS ADMINISTERING A NORMAL SALINE BOLUS SIMULTANEOUSLY ADMINISTERING A UNSPECIFIED PAIN MEDICATION WHEN A LEAK WAS OBSERVED. UPON CLOSER OBSERVATION THE USER NOTICED A SLIT/HOLE IN THE TUBING PROXIMAL TO PATIENT, PAST SECOND PORT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773089 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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