MaxGuard ME5303Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, 19 cm (7.5 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD MaxGuard ME5303 is a short pressure-rated extension set used for IV tubing. The 47 reports mostly describe the blue clamp and tubing cracking or breaking — sometimes while disconnecting from other tubing, sometimes on its own — with one report of leaking and one of the set sticking to IV tubing. No deaths or injuries were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10885403274435), received between Jan 17, 2019 and Mar 18, 2020 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Break” (39 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break39
- Crack8
- Disconnection1
- Fluid/Blood Leak1
Patient problems
- No Information39
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED FROM THE PREOPERATIVE CARE THAT THE BLUE CLAMP ON THE TUBING SET CRACKED CAUSING LEAKS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 9851354 ↗MalfunctionMar 18, 2020Break; Disconnection; Break; Disconnection
IT WAS REPORTED THAT THE EXTENSION SET WAS STUCK TO THE IV TUBING SET WHEN ATTEMPTING TO EXCHANGE TUBING FOR A CAP. THE TUBING SET IS DIFFICULT TO DISCONNECT AND BREAKS WHEN TRYING TO DISLODGE FROM EXTENSION SET. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9850943 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9359376 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9359365 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9359363 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9359312 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9358505 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9358441 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9358134 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9357839 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9357831 ↗MalfunctionNov 21, 2019Break; Break
IT WAS REPORTED THAT ME 5303 IV EXTENSION CLAMP BROKE AND WAS REPLACED WITH NEW EXTENSION.
Patient problems: No Information
MAUDE report 9355590 ↗MalfunctionOct 11, 2019Crack; Crack
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATED, "CAREFUSION MAXGUARD PRESSURE RATED EXTENSION SET, ME5303, LOT 15125541 WE RECENTLY STARTING USING THIS EXTENSION TUBING WE HAVE HAD MULTIPLE REPORTS OF THE BLUE CLAMP CRACKING WHEN SLIDING THE CLAMP INTO PLACE WITH NORMAL AMOUNT OF PRESSURE THIS RENDERS IT INEFFECTIVE AND HAS ALSO CAUSED LEAKING ONTO FLOOR OR PATIENT." THERE WAS NO CUSTOMER HARM. RECEIVED A COPY OF THE CUSTOMER'S ADDITIONAL INFORMATION LETTER FROM FDA WHICH STATES, ¿CAREFUSION MAXGUARD PRESSURE RATED EXTENSION SET, ME5303, LOT 15125541. WE RECENTLY STARTING USING THIS EXTENSION TUBING. WE HAVE HAD MULTIPLE REPORTS OF THE BLUE CLAMP CRACKING WHEN SLIDING THE CLAMP INTO PLACE WITH NORMAL AMOUNT OF PRESSURE. THIS RENDERS IT INEFFECTIVE AND HAS ALSO CAUSED LEAKING ONTO FLOOR OR PATIENT. MANUFACTURER RESPONSE FOR TUBE - IV/OXYGEN/PRESSURE/SUCTION (INCLUDES IV EXTENSION), MAXGUARD PRESSURE RATED EXTENSION SET/ME5303 (PER SITE REPORTER). MANUFACTURER FOUND THAT THE ISSUE WAS DUE TO A FAULT DURING THE MANUFACTURING PROCESS."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9178975 ↗MalfunctionMay 9, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8597577 ↗MalfunctionMay 7, 2019Break; Break
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PRODUCT CAREFUSION MAXGUARD PRESSURE RATED EXTENSION SET, ME5303, LOT 15125541 WE RECENTLY STARTING USING THIS EXTENSION TUBING WE HAVE HAD MULTIPLE REPORTS OF THE BLUE CLAMP CRACKING WHEN SLIDING THE CLAMP INTO PLACE WITH NORMAL AMOUNT OF PRESSURE THIS RENDERS IT INEFFECTIVE AND HAS ALSO CAUSED LEAKING ONTO FLOOR OR PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED.
Patient problems: No Information
MAUDE report 8587961 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED. A COPY OF THE CUSTOMER'S MEDWATCH REPORT WAS RECEIVED FROM THE FDA STATING, "FIVE ADDITIONAL IV EXTENSIONS SETS WITH BROKEN CLAMP GIVEN TO TURN OVER TO CLINICAL ENGINEERING. FACILITY CONTINUES TO HAVE ISSUES WITH BLUE SLIDE CLAMP ON EXTENSION CRACKING WHEN USED. ADDITIONALLY, IT WAS REPORTED TO ME THAT ANESTHESIOLOGISTS ARE REPORTING DIFFICULTY TAPING EXTENSION TUBING IN PLACE AS THE TUBING IS TOO RIGID THIS IS RESULTING IN TUBING GETTING CAUGHT ON THINGS AND IVS ACTUALLY OR POTENTIALLY BEING PULLED OUT."
Patient problems: No Information
MAUDE report 8395232 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8395225 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394939 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394884 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394883 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394881 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394821 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394820 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394702 ↗MalfunctionMar 6, 2019Break; Break
THE CUSTOMER REPORTED THAT THE SLIDE CLAMP ON THE EXTENSION SET BREAKS. THE BROKEN CLAMP DOES NOT PREVENT FLOW, THEREFORE, THE NURSES CONTINUE TO INFUSE WITH THE SET. ALTHOUGH REQUESTED THERE WAS NO OTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8394549 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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