ULTRASITE® 415110Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04022495769923), received between Nov 18, 2016 and Jun 9, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: WHILE IV CONTRAST WAS BEING ADMINISTERED, BRAUN IV TUBE CAP CAME OFF THE IV TUBING. BLOOD AND IV CONTRAST SPILLED ONTO FLOOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25449963 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WHEN ATTACHING THE ULTRASITE TO THE IV CATHETER AND SECURE IT, BLOOD STARTS POURING OUT OF THE SITE. SO, ULTIMATELY IT IS NOT GETTING A GOOD SEAL. THEY ALL LOOK THE SAME AND WE ARE UNABLE TO TELL IF IT IS OK UNTIL WE TRY TO LOCK IT INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645334 ↗
• MalfunctionMar 16, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION SUMMARY: RN WAS FLUSHING PATIENT'S CAP (B BRAUN ULTRASITE INJECTION SITE CAP REF: 415110 LOT#0061960991) AND BLOOD WAS LEAKING OUT AT THE CONNECTION WHERE IT SHOULDN'T BE LEAKING OUT OF. ALL CAPS FROM SAME LOT# PULLED. VERIFIED LOT 0061966510 GOES WITH 490102. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615364 ↗
• MalfunctionMar 15, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE PRODUCT KEEPS BREAKING AND THE PATIENTS ARE SPEWING BLOOD EVERYWHERE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613674 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THERE SEEMS TO BE AN EXTRA PIECE OF PLASTIC ATTACHED AND WHEN YOU USE IT BLOOD COME OUT OF THE PLASTIC ATTACHMENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344167 ↗
• MalfunctionJan 31, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING AT CONNECTION POINT BETWEEN ULTRASITE AND IVC. DETAILED INQUIRY DESCRIPTION: WHEN ATTACHING THE ULTRASITE TO THE IV CATHETER AND SECURE IT, BLOOD STARTS POURING OUT OF THE SITE. SO, ULTIMATELY IT IS NOT GETTING A GOOD SEAL. THEY ALL LOOK THE SAME AND WE ARE UNABLE TO TELL IF IT IS OK UNTIL WE TRY TO LOCK IT INTO THE CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21286726 ↗
• MalfunctionDec 18, 2023Leak/Splash; Leak/Splash

  AS REPORTED PER MEDWATCH MW5148279: "THE PATIENT REPORTED THAT SHE WAS HAVING SOME BLEEDING THAT WAS COMING FROM THE AREA AROUND CONNECTION FROM HER ULTRASITE VALVE AND CADD EXT SET. THE PATIENT STATED THAT HER LINE WAS WELL FASTENED AND SHE COULDN'T TELL WHERE THE ISSUE WAS COMING FROM. THE PATIENT REPORTED THAT SHE HAD ALREADY REPLACED HER VALVE AND LINE AND EVERYTHING SEEMS TO BE WORKING FINE. THE PATIENT STATED HER MAIN CONCERN WAS THAT SHE HAD THIS ISSUE ABOUT 3 WEEKS AGO, BUT SHE NEVER REPORTED IT AND WANTED TO KNOW IF THERE HAVE ANY REPORTS OF SIMILAR ISSUES OR IF THERE WAS A RECALL OF EITHER ITEM. PATIENT HAD NO OTHER QUESTIONS/CONCERNS AT THIS TIME. THE PATIENT DID NOT MISS ANY DOSES AS A RESULT OF ISSUE. ADVERSE EVENT DATES ARE UNKNOWN. THE OUTCOME OF THIS EVENT IS UNKNOWN AS PT DID NOT REPORT EVENT DATES UNKNOWN AS PT DIDN'T REPORT THEM. LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO FURTHER INFORMATION IS KNOWN OR GIVEN. REFERENCE REPORT MW5148280. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER" BRAND NAME: ULTRA SITE 2 WAY CAPLESS VALVE COMMON DEVICE NAME: SET, ADMINISTRATION, INTRAVASCULAR PRODUCT CODE: FPA MANUFACTURER NAME AND ADDRESS: B. BRAUN MEDICAL INC. MODEL #: 41511

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18346343 ↗
• MalfunctionDec 18, 2023Leak/Splash; Leak/Splash

  AS REPORTED PER MEDWATCH MW5148280: THE PATIENT REPORTED THAT SHE WAS HAVING SOME BLEEDING THAT WAS COMING FROM THE AREA AROUND CONNECTION FROM HER ULTRASITE VALVE AND CADD EXT SET. THE PATIENT STATED THAT HER LINE WAS WELL FASTENED AND SHE COULDN'T TELL WHERE THE ISSUE WAS COMING FROM. THE PATIENT REPORTED THAT SHE HAD ALREADY REPLACED HER VALVE AND LINE AND EVERYTHING SEEMS TO BE WORKING FINE. THE PATIENT STATED HER MAIN CONCERN WAS THAT SHE HAD THIS ISSUE ABOUT 3 WEEKS AGO, BUT SHE NEVER REPORTED IT AND WANTED TO KNOW IF THERE HAVE ANY REPORTS OF SIMILAR ISSUES OR IF THERE WAS A RECALL OF EITHER ITEM. PATIENT HAD NO OTHER QUESTIONS/CONCERNS AT THIS TIME. THE PATIENT DID NOT MISS ANY DOSES AS A RESULT OF ISSUE. ADVERSE EVENT DATES ARE UNKNOWN. THE OUTCOME OF THIS EVENT IS UNKNOWN AS PT DID NOT REPORT EVENT DATES UNKNOWN AS PT DIDN'T REPORT THEM. LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO FURTHER INFORMATION IS KNOWN OR GIVEN. REFERENCE REPORT MW5148279. REPORTED TO (B)(6) BY: PATEINT/CAREGIVER. BRAND NAME: ULTRA SITE 2 WAY CAPLESS VALVE COMMON DEVICE NAME: SET, ADMINISTRATION, INTRAVASCULAR PRODUCT CODE: FPA MODEL #: 415110 TYPE OF EVENT: SERIOUS INJURY HEALTH EFFECT - CLINIC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18344447 ↗
• MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE PATIENT: "AS I WAS PRIMING MY NEW EXTENSION SETS FOR THE WEEK, I ONCE AGAIN HAD THE LIGHT GREEN FEMALE LUER ATTACHMENT UNCAPPED BEFORE OPENING THE PACKAGE ON THE 6" Y EXTENSION. I'VE ALSO EXPERIENCED MILD LEAKING WHEN INFUSING BETWEEN THE GREEN FEMALE LUER AND BOTH THE ULTRASITE (415110) OR THE BACKCHECK FLOW VALVE (415062)." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786939 ↗
• MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: "WHEN A 24 GAUGE IV WAS PLACED IN A PATIENT, BLOOD LEAKED AROUND BOTH THE CATHETER AND THE ULTRASITE VALVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10843840 ↗
• MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLACK GREASY SUBSTANCE WAS SEEN ON THE VALVE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595931 ↗
• MalfunctionOct 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS PER MEDWATCH NUMBER: MW5079468. PATIENT REQUESTED A NURSE VISIT HER BECAUSE SHE WAS EXPERIENCING BACK FLOW OF BLOOD SINCE SWITCHING TO B. BRAUN ULTRASITE, LOT # 0061579511, EXP 08/31/2022, LEAKING BLOOD FROM SITE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953687 ↗
• MalfunctionJan 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: LEAKAGE OF CHEMOTHERAPY OCCURRED AT THE ULTRASITE VALVE ON A PICC LINE WHEN CONNECTED TO THE HALYARD C-SERIES ELASTOMERIC PUMPS. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169045 ↗
• MalfunctionOct 8, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE ULTRASITE VALVE LEAKED CHEMOTHERAPY DURING USE. THE LEAK WAS NOT DISCOVERED UNTIL THE END OF THERAPY BECAUSE PATIENT WAS UNDER A BLANKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL TREATMENT DUE TO THE CHEMO LEAKING. CHEMOTHERAPY BEING INFUSED WERE VINCRISTINE AND DOXORUBICIN. A CHEMO SPILL KIT WAS USED TO CLEAN UP THE LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927862 ↗
• MalfunctionNov 30, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: THERE WAS A SLOW BLOOD LEAK FROM THE BACK OF THE CLAVE WHERE IT SCREWS IN TO THE IV CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6134560 ↗
• MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: EVENT # 2: REPORTS THE PUMP TUBING UNRAVELED FROM THE ULTRASITE VALVE. THE PATIENT WAS SCHEDULED FOR C6 FOLFOX. THE PHARMACY PREPARED THE 5FU CONTINUOUS INFUSION DOSE IN A C270050 IFLOW HOME PUMP C-SERIES PER THE INSTRUCTIONS OF THE MANUFACTURER. THE 5FU WAS PREPARED IN THE HOMEPUMP C-SERIES AT 11:09 AM ON (B)(6) 2014. VOLUME OF 5FU = 93.12 ML AND VOLUME OF NORMAL SALINE = 136.88 ML. TOTAL VOLUME IN THE PUMP = 230 ML. THE TREATING NURSE WAS ATTACHING THE PUMP TO THE PATIENT AT 3:45PM. THE NURSE ATTACHED THE LUER LOCK CONNECTOR OF THE HOMEPUMP TO THE ULTRASITE ACCESS DEVICE. THE LUER LOCK CONNECTOR IMMEDIATELY STARTED TO TURN BACK OFF OF THE ULTRASITE INJECTION SITE AND DISCONNECT. THE PHARMACY PREPARED ANOTHER DOSE IN A NEW IFLOW HOMEPUMP C-SERIES ELASTOMERC PUMP AT 4:25PM. THE NURSE TRIED TO CONNECT AT 4:30PM AND THE SAME INCIDENT OCCURRED AGAIN. THE PHARMACY THEN PREPARED A THIRD DOSE AT 4:35PM. THIS TIME THE PHARMACY PLACED THE ULTRASITE INJECTION SITE ONTO THE LUER LOCK CONNECTOR OF THE ELASTOMERIC PUMP DURING COMPOUNDING. THE NURSE ATTACHED IT TO THE PATIENT AT 4:45PM. THE CONNECTION REMAINED. NURSING WAS ABLE TO ATTACH AND THEN TAPED THE CONN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112815 ↗
• MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS THE PUMP TUBING UNRAVELED FROM THE ULTRASITE VALVE. THE PATIENT WAS SCHEDULED FOR C6 FOLFOX. THE PHARMACY PREPARED THE 5FU CONTINUOUS INFUSION DOSE IN A C270050 IFLOW HOME PUMP C-SERIES PER THE INSTRUCTIONS OF THE MANUFACTURER. THE 5FU WAS PREPARED IN THE HOMEPUMP C-SERIES AT 11:09 AM ON (B)(6) 2014. VOLUME OF 5FU = 93.12 ML AND VOLUME OF NORMAL SALINE = 136.88 ML. TOTAL VOLUME IN THE PUMP = 230 ML. THE TREATING NURSE WAS ATTACHING THE PUMP TO THE PATIENT AT 3:45PM. THE NURSE ATTACHED THE LUER LOCK CONNECTOR OF THE HOMEPUMP TO THE ULTRASITE ACCESS DEVICE. THE LUER LOCK CONNECTOR IMMEDIATELY STARTED TO TURN BACK OFF OF THE ULTRASITE INJECTION SITE AND DISCONNECT. THE PHARMACY PREPARED ANOTHER DOSE IN A NEW IFLOW HOMEPUMP C-SERIES ELASTOMERC PUMP AT 4:25PM. THE NURSE TRIED TO CONNECT AT 4:30PM AND THE SAME INCIDENT OCCURRED AGAIN. THE PHARMACY THEN PREPARED A THIRD DOSE AT 4:35PM. THIS TIME THE PHARMACY PLACED THE ULTRASITE INJECTION SITE ONTO THE LUER LOCK CONNECTOR OF THE ELASTOMERIC PUMP DURING COMPOUNDING. THE NURSE ATTACHED IT TO THE PATIENT AT 4:45PM. THE CONNECTION REMAINED. NURSING WAS ABLE TO ATTACH AND THEN TAPED THE CONN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112810 ↗