MaxPlus MPX5305-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, with clear needleless connector and Y-site 19 cm (7.5 in) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403274619), received between Jul 21, 2025 and Jul 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Jun 16, 2026Open, Classified
Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
Z-2941-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY HAD ISSUES WITH LEAKING MIDPOINT UP TUBING DURING INFUSIONS, MEDICATION ADMINS AND HAVE HAD BLOOD LEAK DURING NON-LOCKED USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561569 ↗MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT SEVERAL TUBING ARE LEAKING AT MIDPOINT. APPEARS MAY BE A BAD LOT AND FLAW IN PLASTIC MERGE TO WHERE PORT IS AT MIDPOINT IN LINE. THEY HAVE HAD IVF, BLOOD AND MEDICATIONS LEAK FROM FLAW SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561204 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.