MaxPlus MP5305-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, with removable clear needleless connector 18 cm (7 in) · Class 2
All models of MaxPlus (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403236679), received between Dec 29, 2020 and Sep 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage2
- Component Missing2
- Restricted Flow rate2
- Defective Device1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT WE ATTACH A SALINE FLUSH TO THE EXTENSION SET TO FLUSH SALINE THROUGH THE LINE BEFORE ATTACHING TO THE PATIENT'S IV CATHETER. THE SALINE WILL NOT FLUSH THROUGH THE TUBE AT ALL. WE EVEN TRIED DETACHING EVERYTHING FROM THE TUBE ITSELF AND NOTHING WILL FLUSH THROUGH. AFTER FURTHER INVESTIGATION, THE TUBE ITSELF HAS NOT BEEN HOLLOWED OUT. THERE IS STILL A SECTION WHERE THE TUBING IS COMPLETELY CLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001353 ↗MalfunctionOct 16, 2024Component Missing; Component Missing
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR WAS MISSING A COMPONENT THE FOLLOWING ISSUE WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: MY CUSTOMER RECEIVED ITEM: MP5305-C, BUT IT IS MISSING THE CLAMP. DID BD TAKE THIS OUT OF THE KIT OR IS THIS A QUALITY ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20467990 ↗MalfunctionJun 19, 2024Component Missing; Component Missing
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567517 ↗MalfunctionDec 29, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE 7-IN PRESSURE RATED SET W/ MAXPLUS WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MP5305-C BATCH/ LOT #: 20055016 MAXPLUS EXTENSION SET, MULTIPLE ATTEMPTS WERE MADE TO FLUSH THROUGH BUFF CAP ON END OF EXTENSION SET (WITH VARIOUS FROM SAME LOT NUMBER) AND WERE UNABLE.
Patient problems: Insufficient Information
MAUDE report 11092679 ↗MalfunctionDec 29, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE 7-IN PRESSURE RATED SET W/ MAXPLUS WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 2: MATERIAL #: MP5305-C , BATCH/ LOT #: 20055016. MULTIPLE ATTEMPTS WERE MADE TO FLUSH THROUGH BUFF CAP ON END OF EXTENSION SET (WITH VARIOUS FROM SAME LOT NUMBER) AND WERE UNABLE. HAD TO CHANGE BUFF CAP AND ABLE TO FLUSH AND INFUSE IVF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11092652 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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