MaxGuard MX9060Recalls & reported problems
BD Switzerland Sàrl · Kink resistant extension set, with needleless Y-site 20.5 cm (8 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403237591), received between Nov 14, 2022 and Jun 30, 2026 — classified as 7 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. 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/Splash3
- Complete Blockage2
- Blocked Connection1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THEY PULLED BACK FROM THE OPEN END OF THE EXTENSION TUBING TO WASTE BLOOD, AND BLOOD AND SALINE BEGIN LEAKING OUT OF THE Y-SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667852 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SET BROKE WHILE IN USE ON A PATIENT. THE EXTENSION SET FAILED AT ITS OWN Y-SITE PORT ATTACHMENT, NOT AT THE CONNECTION WITH ANY OTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494181 ↗MalfunctionJun 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SET BROKE WHILE IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312995 ↗MalfunctionJun 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SET BROKE WHILE IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312991 ↗MalfunctionNov 15, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE WERE BLOCKED WHILE FLUSHING THE Y-SITE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT TOOK EXCESSIVE FORCE TO FLUSH THE Y-SITE. THE DIFFICULTY APPEARS TO HAPPEN AT THE BLUE "STOPPER" THAT IS IN THE PORT. I HAD TWO OF THESE THAT THIS HAPPENED WITH OVERNIGHT BUT HAVE HAD THIS ISSUE MULTIPLE TIMES OVER THE PAST COUPLE OF MONTHS AS HAVE OTHER NURSES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15801182 ↗MalfunctionNov 15, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE WAS BLOCKED WHILE FLUSHING THE Y-SITE. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT TOOK EXCESSIVE FORCE TO FLUSH THE Y-SITE. THE DIFFICULTY APPEARS TO HAPPEN AT THE BLUE "STOPPER" THAT IS IN THE PORT. I HAD TWO OF THESE THAT THIS HAPPENED WITH OVERNIGHT BUT HAVE HAD THIS ISSUE MULTIPLE TIMES OVER THE PAST COUPLE OF MONTHS AS HAVE OTHER NURSES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15801181 ↗MalfunctionNov 14, 2022Blocked Connection; Blocked Connection
IT WAS REPORTED BY THE CUSTOMER THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED LIQUID FLOW THOUGH WHILE CONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT IS NOT LETTING LIQUID FLOW THOUGH WHILE CONNECTED BUT DOES ALLOW LIQUID FLOW WHEN NOT CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794891 ↗
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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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