SURECAN SAFETY IIRecalls & reported problems across all models

We found 8 models of SURECAN SAFETY II by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between May 17, 2018 and May 12, 2022 — classified as 4 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SURECAN SAFETY II problems

SURECAN SAFETY II models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SURECAN SAFETY II 4447006-02

  Non-Coring (Huber) Needle
  13 reports
• SURECAN SAFETY II 4447005-02

  Non-Coring (Huber) Needle
  6 reports
• SURECAN SAFETY II 4447012-02

  Non-Coring (Huber) Needle
  4 reports
• SURECAN SAFETY II 4447007-02

  Non-Coring (Huber) Needle
  3 reports
• SURECAN SAFETY II 4447051-02

  Non-Coring (Huber) Needle
  3 reports
• SURECAN SAFETY II 4447000-02

  Non-Coring (Huber) Needle
  2 reports
• SURECAN SAFETY II 4447010-02

  Non-Coring (Huber) Needle
  2 reports
• SURECAN SAFETY II 4447011-02

  Non-Coring (Huber) Needle
  1 report

Recent SURECAN SAFETY II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE NURSE ACCESSED THE PATIENT'S PORT WITH THE NEW 20G PORT NEEDLES. WHEN THE NURSE DREW BACK, BLOOD IMMEDIATELY BEGAN SEEPING AROUND THE NEEDLE AND RUNNING DOWN THE PATIENT'S CHEST. IT REQUIRED THE NURSE TO REMOVE THE NEEDLE AND APPLY LIGHT PRESSURE FOR 30 SECONDS AND RE-ACCESS PORT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14371671 ↗
• MalfunctionFeb 14, 2022Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: "THE NEEDLE COVER WOULD NOT LOCK INTO PLACE RESULTING IN A NURSE GETTING STUCK WITH THE NEEDLE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 13524706 ↗
• MalfunctionFeb 9, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: "THE NEEDLE COVER WOULD NOT LOCK INTO PLACE RESULTING IN A NURSE GETTING STUCK WITH THE NEEDLE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 13500349 ↗
• MalfunctionJan 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  I ACCESSED THE ABOVE PATIENT'S PORT WITH THE NEW 20G PORT NEEDLES. WHEN I DREW BACK, BLOOD IMMEDIATELY BEGAN SEEPING AROUND THE NEEDLE AND RUNNING DOWN THE PATIENT'S CHEST. IT REQUIRED ME TO REMOVE THE NEEDLE AND APPLY LIGHT PRESSURE FOR 30 SECONDS AND RE-ACCESS PORT.

  Patient problems: Extravasation

  MAUDE report 13383751 ↗
• MalfunctionDec 29, 2021Device Handling Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: 2 NEEDLESTICKS OCCURRED WITH STAFF- ONE WITH CLEAN NEEDLE WHILE TRYING TO REATTACH THE BASEPLATE. ONE WAS WITH NEEDLE THAT HAD BEEN ACCESSED. IT IS REPORTED THAT NURSE STUCK HERSELF WHEN TRYING TO READJUST THE NEEDLE. IT IS UNKNOWN IF THE NEEDLE WAS CLEAN OR HAD ALREADY BEEN USED AT THE TIME OF INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13112631 ↗
• MalfunctionDec 8, 2021Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: THE SURECAN NEEDLE DID NOT LOCK IN PLACE RESULTING IN NEEDLESTICK FOR RN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12963139 ↗
• MalfunctionNov 4, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1. CUSTOMER REPORTS THAT THE PASSIVE SAFETY SHIELD FAILED TO ENGAGE ALL THE WAY AND RESULTED IN A NEEDLESTICK INJURY. CUSTOMER STATES IT HAPPENED TWICE TO TWO DIFFERENT CLINICIANS (SAME LOT NUMBER).

  Patient problems: Needle Stick/Puncture

  MAUDE report 12752368 ↗
• MalfunctionNov 4, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2. CUSTOMER REPORTS THAT THE PASSIVE SAFETY SHIELD FAILED TO ENGAGE ALL THE WAY AND RESULTED IN A NEEDLESTICK INJURY. CUSTOMER STATES IT HAPPENED TWICE TO TWO DIFFERENT CLINICIANS (SAME LOT NUMBER).

  Patient problems: Needle Stick/Puncture

  MAUDE report 12752364 ↗
• MalfunctionFeb 5, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY USER FACILITY: THE RN WAS REMOVING IT FROM THE PATIENT'S PORT POST INFUSION AND THE SAFETY DID NOT FULLY ENGAGE (SO THE NEEDLE WAS STILL EXPOSED). HER RIGHT THUMB WAS SCRATCHED BY THE NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11285821 ↗
• MalfunctionAug 14, 2020Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem

  AS REPORTED ON MEDWATCH MW5095237: SAFETY DEVICE ON HUBER NEEDLE DID NOT STAY ENGAGED ON NEEDLE TIP, WHICH CAUSED A NEEDLE STICK WHEN PLACING THE DEVICE IN THE SHARPS CONTAINER.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10408763 ↗
• MalfunctionAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: AFTER FLUSHING THE NEEDLE/CATHETER AND INSERTING INTO THE PATIENT'S ACCESS PORT, BLOOD WAS LEAKING AT THE JUNCTION OF THE DEVICE HUB AND THE NEEDLE WHEN THE NURSE ATTEMPTED TO WITHDRAW BLOOD TO VERIFY PLACEMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10408761 ↗
• MalfunctionAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: AFTER FLUSHING THE NEEDLE/CATHETER AND INSERTING INTO THE PATIENT'S ACCESS PORT, BLOOD WAS LEAKING AT THE JUNCTION OF THE DEVICE HUB AND THE NEEDLE WHEN THE NURSE ATTEMPTED TO WITHDRAW BLOOD TO VERIFY PLACEMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10408754 ↗
• MalfunctionMay 11, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: AFTER DEACCESSING A PORT-A-CATH, THE PORT NEEDLE SAFETY ENGAGED, BUT DID NOT FULLY LOCK INTO PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10043332 ↗
• MalfunctionApr 15, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: NEEDLE REMOVED FROM PATIENT AND SAFETY FEATURE MALFUNCTIONED AND CAME OFF DURING REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961810 ↗
• MalfunctionMar 16, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: THE SAFETY MECHANISM DID NOT ENGAGE WHICH RESULTED IN THE PATIENT'S SKIN TEARING.

  Patient problems: Skin Tears

  MAUDE report 9834547 ↗

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