MaxPlus MP5302-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, (minibore) with clear needleless connector 21.5 cm (8.5 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403230134), received between Oct 22, 2020 and Dec 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705083 ↗MalfunctionSep 13, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20218087 ↗MalfunctionOct 22, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 8.5 IN PRESSURE RATED MINIBORE SET TUBING SPLIT OPEN AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, MP5302-C BATCH NO: UNKNOWN IT WAS REPORTED THAT THERE WAS A SAFETY EVENT WHERE THE ED USED THIS TUBING AND TRIED TO INJECT CONTRAST FOR THE CT, BUT THE TUBING SPLIT OPEN AND CONTRAST LEAKED ALL OVER THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10722897 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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