MaxGuard ME2017Recalls & reported problems
BD Switzerland Sàrl · Extension Set (ultra minibore) 152.4 cm (60 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD MaxGuard extension set is a tubing set used for intravenous lines. Many of the 137 reports describe the tubing breaking, cracking or leaking, sometimes at the hub or connection, and some describe a line having to be replaced during treatment. There are no deaths and 1 injury. 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
- 137
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10885403236242), received between Feb 11, 2019 and Sep 6, 2022 — classified as 1 injury, 136 malfunctions.
The most frequently reported specific device problem is “Break” (56 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
- Break56
- Insufficient Device Problem Information33
- Leak/Splash29
- Crack17
- Fluid/Blood Leak5
- Infusion or Flow Problem3
- Material Separation3
- Disconnection2
Patient problems
- No Information74
- No Consequences Or Impact To Patient52
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement3
- Underdose3
- Low Blood Pressure/ Hypotension1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET TUBING SNAPPED IN HALF AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE TUBING SNAPPED IN HALF WHEN RN WENT TO PLACE LABEL ON IT. SYRINGE TUBING ALREADY IN LINE WITH MORPHINE CONTINUOUSLY INFUSING TO PATIENT. PATIENT HAD A 1 MINUTE PAUSE IN THEIR CONTINUOUS MORPHINE AND REQUIRED NEW TUBING TO BE PRIMED AND REATTACHED TO LINES." "DID YOU EXPERIENCED ANY LEAKAGE DUE TO THE REPORTED FAILURE? YES. PUMP WAS PAUSED IMMEDIATELY AND NO HARM CAME TO PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15366937 ↗MalfunctionJun 29, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A 60 IN ULTRA MINIBORE EXTENSION SET WAS FOUND TO BE DAMAGED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "STUDENT RN WAS SCREWING FLUSH ONTO MED LINE TUBING PER PROTOCOL AND TUBING CRACKED AT HUB. CRACKED LINE MED WAS SAVED AND PLACED IN LEADERSHIP OFFICE AND NEW MED LINE WAS CREATED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089719 ↗MalfunctionJun 29, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 60 IN ULTRA MINIBORE EXTENSION SET WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER, THE HUB OF THE TUBING CRACKED, CAUSING A LEAK AND RENDERING THE LINE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089656 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 60 IN ULTRA MINIBORE EXTENSION SET TUBING CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017, BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT WHEN THE TUBING WAS DISCONNECTED FROM THE PATIENTS PICC LINE, THE TUBING CRACKED AT THE CONNECTION SITE. VERBATIM: IV TUBING BROKE OFF IN THE PORT OF PATIENT'S PIV. NURSE WAS ABLE TO SAVE PIV. MEDLINE TUBING CONNECTED TO PATIENT WITHOUT ISSUE OR CONCERN BY THIS RN. MEDICATION INFUSION COMPLETED, THIS RN DISCONNECTED MEDLINE TUBING FROM PATIENT'S PICC LINE AND THE TUBING CRACKED AT THE SITE THAT CONNECTS TO THE NEEDLELESS HUB. THE PORTION THAT CRACKED REMAINED LODGED IN THE PICC CAP HUB. PRESSURE MAINTAINED KEEPING THE LINE OPEN. LINE WAS CLAMPED AND HUB WRAPPED WITH ALCOHOL SWAB. CAUSED CAP ON LINE TO NEED CHANGING INCREASING ADDITIONAL EXPOSURE. IV TUBING AND PICC CAP HUB SAVED.
Patient problems: No Code Available
MAUDE report 10892074 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 60 IN ULTRA MINIBORE EXTENSION SET TUBING BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017 BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE TUBING BROKE AT THE HUB WHILE ATTACHING TO THE PATIENTS PIV. VERBATIM: MED INFUSION PUMP TUBING BROKE AT THE HUB WHEN ATTACHING TO THE PATIENTS PIV. TUBING SAVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891679 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 60 IN ULTRA MINIBORE EXTENSION SET TUBING CRACKED WHILE BEING DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017 BATCH/ LOT #: UNKNOWN IT WAS REPORTED THAT THE END PIECE OF THE TUBING CRACKED WHILE BEING DISCONNECTED. VERBATIM: RN WENT TO FLUSH AND HEP LOCK PICC LINE AFTER ABX FINISHED INFUSING. WHEN DISCONNECTING THE TUBING, THE END PIECE OF THE TUBING CRACKED OFF AND REMAINED IN THE CAP OF THE RED LUMEN OF PT'S PICC. RN CHANGED CAP AND SAVED THE CRACKED TUBING AND CAP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891664 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 60 IN ULTRA MINIBORE EXTENSION SET EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017 BATCH/ LOT #: UNKNOWN IV TUBING BROKE OFF IN THE PORT OF PATIENT'S PIV. NURSE WAS ABLE TO SAVE PIV.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891662 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 60 IN ULTRA MINIBORE EXTENSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017, BATCH/ LOT #: UNKNOWN. I WAS STARTING AN ANTIBIOTIC ON PATIENT AND THE END PLASTIC PIECE BROKE OFF. OUTCOME - HAD TO REPLACE ENTIRE LINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891601 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A 60 IN ULTRA MINIBORE EXTENSION SET EXPERIENCED COMPONENT SEPARATION AND LEAKAGE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CENTER PART OF THE TUBE BROKE OFF IN THE HUB. THIS RESULTED IN THE TUBE LEAKING WHEN DISCONNECTED. VERBATIM: THE CENTER PART OF THE TUBING BROKE OFF IN THE HUB OF THE SEPTI-FUSE, AND WHEN DISCONNECTED THE IVF CONTINUALLY DRIPPED OUT OF THE TUBING"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891584 ↗MalfunctionNov 24, 2020Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem
IT WAS REPORTED 60 IN ULTRA MINIBORE EXTENSION SET HAD A CRACK AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017 , BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE TUBING HAD A CRACK NEAR THE ATTACHMENT SITE, WHICH RESULTED IN LEAKING OF THE TUBE. CRACK IN MEDICINE TUBING AT ATTACHMENT NEAR THE MEDICATION END. UNSURE IF ALL MEDICATION WAS DELIVERED DUE TO THE TUBING BEING WET HIGH SUSPICION FOR SOME/ALL OF MEDICATION NOT DELIVERED TO PATIENT. THE PATIENT IS BEING WEANED FROM THIS MEDICATION CURRENTLY AND THE PROVIDER HAS LOW CONCERN FOR ANY ADVERSE OUTCOME TO THE PATIENT.
Patient problems: Underdose
MAUDE report 10891578 ↗MalfunctionNov 24, 2020Backflow; Leak/Splash; Backflow; Leak/Splash
IT WAS REPORTED THAT THE 60 IN ULTRA MINIBORE EXTENSION SET EXPERIENCED CRACKS -MICROCHANNEL ISSUES AND BLOOD BACKFLOW DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2017, BATCH/ LOT #: UNKNOWN. RN CHANGED OUT PT DEXMED DRIP. UPON DOING HER SAFETY CHECKS, RN NOTICED PT'S DRIP LINE WAS BACKING UP WITH BLOOD AND THERE WAS FLUID ON THE FLOOR. UPON FURTHER INSPECTION, RN NOTED THAT THE TUBING WHERE THE DEXMED WAS RUNNING HAD CRACKED AT THE END AND WAS RUNNING ONTO THE FLOOR,
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891471 ↗MalfunctionNov 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 60 IN ULTRA MINIBORE EXTENSION SET TUBING LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING AND/OR CONNECTION SITE LEAKING ( A FEW DROPS). TUBING CHANGED AND SAVED TO GIVE TO SUPERVISOR. (BIOMED WAS UNABLE TO DUPLICATE LEAK WITH GIVEN TUBING)".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891341 ↗MalfunctionAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN UNEXPECTED EXTENSION TUBING SET WITH AN UNSPECIFIED ISSUE WAS RETURNED BY THE CUSTOMER. THE CUSTOMER STATED THAT THERE IS NO EVENT INFORMATION AVAILABLE.
Patient problems: No Information
MAUDE report 10457244 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
UNEXPECTED RETURN WITH UNSPECIFIED FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDE.
Patient problems: No Information
MAUDE report 10376208 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PRODUCT WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNSPECIFIED FAILURE.
Patient problems: No Information
MAUDE report 10376203 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN UNEXPECTED TUBING SET WITH AN UNSPECIFIED ISSUE WAS RETURNED BY THE CUSTOMER. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 10376086 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PRODUCT WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNSPECIFIED FAILURE.
Patient problems: No Information
MAUDE report 10376085 ↗MalfunctionAug 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALTHOUGH AN UNEXPECTED TUBING SET WITH AN UNSPECIFIED ISSUE WAS RETURNED BY THE CUSTOMER, A PHOTO TAKEN BY THE RECEIVING LAB APPEARED TO SHOW A BROKEN LUER. THIS PHOTO OBSERVATION IS UNCONFIRMED AND WILL BE VERIFIED THROUGH FAILURE INVESTIGATION. NO FURTHER INFORMATION WAS MADE AVAILABLE TO DATE.
Patient problems: No Information
MAUDE report 10371287 ↗MalfunctionAug 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE TUBING SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNSPECIFIED FAILURE. THE CUSTOMER STATED THAT THERE IS NO EVENT INFORMATION AVAILABLE.
Patient problems: No Information
MAUDE report 10367280 ↗MalfunctionJul 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN UNKNOWN FAILURE WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 10328566 ↗MalfunctionJul 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALTHOUGH AN UNEXPECTED TUBING SET WITH AN UNSPECIFIED ISSUE WAS RETURNED BY THE CUSTOMER, A PHOTO FROM THE RECEIVING LAB APPEARED TO SHOW A BROKEN LUER. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 10328506 ↗MalfunctionJul 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN UNKNOWN FAILURE WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 10328470 ↗MalfunctionJul 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN UNKNOWN FAILURE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 10324142 ↗MalfunctionJul 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionJul 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN UNSPECIFIED FAILURE OCCURRED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Information
MAUDE report 10321407 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page