Safsite® 471987Recalls & reported problems
B. Braun Medical Inc. · SET04TSL SMALL BORE T-PORT EXTENSION SET · Class 2
All models of Safsite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046963790110), received between Oct 10, 2018 and Dec 4, 2019 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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.
Most reported problems
Device problems
- Fluid/Blood Leak9
Patient problems
- No Known Impact Or Consequence To Patient7
- Blood Loss2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET DETACHED AND PATIENT HAD 2ML OF BLOOD LOSS.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 9411680 ↗MalfunctionNov 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: DESCRIPTION OF ISSUE: "WE HAVE HAD 3 SITUATIONS WHERE A T CONNECTOR HAS SEPARATED FROM A YELLOW ANGIOCATH. THIS HAS RESULTED IN BLEEDING. THIS HAS OCCURRED IN THE NICU. IT DOES NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV HAS BEEN RUNNING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9363284 ↗MalfunctionNov 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION OF ISSUE: "WE HAVE HAD 3 SITUATIONS WHERE A T CONNECTOR HAS SEPARATED FROM A YELLOW ANGIOCATH. THIS HAS RESULTED IN BLEEDING. THIS HAS OCCURRED IN THE NICU. IT DOES NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV HAS BEEN RUNNING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9363278 ↗MalfunctionNov 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DESCRIPTION OF ISSUE: "WE HAVE HAD 3 SITUATIONS WHERE A T CONNECTOR HAS SEPARATED FROM A YELLOW ANGIOCATH. THIS HAS RESULTED IN BLEEDING. THIS HAS OCCURRED IN THE NICU. IT DOES NOT HAPPEN UNTIL A FEW DAYS AFTER THE IV HAS BEEN RUNNING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9363251 ↗MalfunctionSep 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE PRODUCT LEAKED BLOOD AND FLUID. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8991735 ↗MalfunctionSep 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE PRODUCT LEAKED BLOOD AND FLUID. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8991734 ↗MalfunctionSep 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE PRODUCT LEAKED BLOOD AND FLUID. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8991732 ↗MalfunctionOct 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: BACK FLOW OF BLOOD OCCURRED WHEN THE VALVE DID NOT WORK PROPERLY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7968808 ↗MalfunctionOct 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: BACK FLOW OF BLOOD OCCURRED WHEN THE CUSTOMER REMOVED THE SYRINGE FROM THE T-PORT TUBE AFTER INJECTING DRUG SOLUTION VIA THE SYRINGE, CAUSING BLOOD TO LEAK. NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 7953690 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page