Midline Catheter Kit S4254108BDPRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741154164), received between Aug 6, 2020 and May 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2667-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Deformation

  IT WAS REPORTED END OF PICC "FLIPPING" OR "FOLDING BACK" WHEN THREADING, HAD TO SPEND TIME READJUSTING THE LINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162896 ↗
• MalfunctionSep 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE SAFETY DID NOT FUNCTION PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017631 ↗
• InjuryOct 19, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THE 21G ACCESS NEEDLE SAFETY DID NOT ENGAGE PROPERLY, THE SAFETY WAS SLID DOWN THE SHAFT OF THE NEEDLE AND JUST SLID OFF THE TIP OF THE NEEDLE AND THE CLINICIAN EXPERIENCED A NEEDLE STICK. NO CONSEQUENCES FOR PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20489257 ↗
• MalfunctionDec 13, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE MICROINTRODUCER IS SERRATING AT TIP OF THE SHEATH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973946 ↗
• MalfunctionFeb 11, 2021Fluid/Blood Leak; Unintended Movement

  IT WAS REPORTED THE EXTERNAL PURPLE LUMEN CAME OUT OF THE Y OR WINGS OF THE CATHETER, CLEAN, FULL CATHETER WITHOUT SHARDS OR TEARING; EMPTY HOLE LEAKING NOTED FROM PRIMARY RN. CATHETER WAS TRIMMED TO 18 CM WITH 1 CM OUT, PLACED WITH EASE IN THE BASILIC VESSEL, AND SECURED WITH STATLOCK.

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

  MAUDE report 11313752 ↗
• MalfunctionAug 7, 2020Defective Component; Defective Component

  IT WAS REPORTED: "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378393 ↗
• MalfunctionAug 7, 2020Defective Component; Defective Component

  IT WAS REPORTED: "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378384 ↗
• MalfunctionAug 7, 2020Defective Component; Defective Component

  IT WAS REPORTED: "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378378 ↗
• MalfunctionAug 6, 2020Defective Component; Defective Component

  ON (B)(6) 2020 "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF A 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376773 ↗
• MalfunctionAug 6, 2020Defective Component; Defective Component

  ON (B)(6) 2020 "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF A 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376770 ↗
• MalfunctionAug 6, 2020Defective Component; Defective Component

  ON (B)(6) 2020 "A VIRTUAL DEMONSTRATION OF PROVENA PICC KITS WAS PROVIDED TO VASCULAR ACCESS NURSES AT HOSPITAL. SAMPLES OF A 4FR PROVENA PICC KIT WERE PROVIDED. DURING DISCUSSION NURSES AND BD CS NOTICED THAT PIECES OF GT NEEDLE GUIDE PLASTIC FRAGMENTED OFF AS INSERTION NEEDLE WAS INSERTED INTO EACH OF THE NEEDLE GUIDES. SEVERAL NURSES ATTEMPTED USING THE GT NEEDLE GUIDES WITH THE SAME RESULT OF PLASTIC SHEARING OFF THE CENTER OF THE NEEDLE GUIDE. THIS IS A POTENTIAL PATIENT CARE COMPLICATION BECAUSE THE PLASTIC COULD BECOME AN EMBOLI IN THE PATIENTS BLOOD STREAM." THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376767 ↗