Midline Catheter Kit SP4153108DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741185076), received between Dec 22, 2020 and Aug 11, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Difficult or Delayed Separation

  It was reported that during placement of a midline catheter, the dilator did not split as intended. One of the pull away tabs broke away from the dilator sheath and the dilator could not be removed as designed.The user obtained a new midline kit, removed the defective component, and successfully placed the midline catheter. No complications or patient injury were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216200 ↗
• MalfunctionMar 30, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT THE TRIMMABLE MIDLINE KIT INTRODUCERS BREAKING BEFORE REMOVING FROM THE PATIENT. THERE WAS NO HARM, BUT IT WAS A LITTLE DIFFICULT TO GET OUT OF THE PATIENT'S SKIN WITH NOTHING TO PULL WITH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735652 ↗
• InjuryFeb 17, 2026Difficult or Delayed Separation

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE PLACING A THREE FRENCH SINGLE LUMEN MIDLINE, THE DILATOR SHEATH BROKE OFF INTO THE PATIENT VASCULATURE DURING PEELING OF THE SHEATH. IT WAS REPORTED THAT NO INCREASED FORCE WAS USED AND THE PEEL AWAY PORTION SEPARATED FROM THE HANDLE WHILE THE PRODUCT WAS BEING USED IN THE USUAL MANNER. THE SHEATH WAS LOST IN THE PATIENT AND THE DEBRIS WAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24370733 ↗
• MalfunctionDec 3, 2025Product Quality Problem; Contamination /Decontamination Problem; Product Quality Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY MEDWATCH THAT THE BD PROVENA MIDLINE CATHETER INTERNAL STIFFENING STYLET APPEARS TO HAVE A RESIDUE/SUBSTANCE PRESENT ON NEWLY OPENED STERILE PRODUCT; POSSIBLY SHEARING FROM T-LOCK ASSEMBLY. THIS WAS ON A NEWLY OPENED PACKAGE AND WAS NOT USED ON A PATIENT. RESIDUE WAS NOTED ON THE INTERNAL GUIDEWIRE WHEN ATTEMPTING TO PULL BACK AFTER TRIMMING THE MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708175 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT RETURNED TO THE EMERGENCY ROOM WITH A LEAKING MIDLINE. LINE REMOVED AND A PICC PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181465 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT CAME TO ER WITH LEAKING MIDLINE. MIDLINE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180046 ↗
• InjuryApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER RN WAS PLACING A MIDLINE FOR A PEDIATRIC PATIENT AND AFTER GAINING ACCESS AND THREADING THE WIRE THEY MET RESISTANCE. AFTER ATTEMPTING TO RETRACT THE WIRE IT WOULD NOT RETRACT FROM THE NEEDLE. RN DID REMOVE THE NEEDLE OVER THE WIRE HOWEVER THEY WERE STILL UNABLE TO PULL BACK THE WIRE. X-RAYS WERE TAKEN AND IT WAS OBSERVED THAT THE WIRE TWISTED A KNOT WHICH IS WHY IT WOULD NOT COME OUT OF THE SKIN/VEIN. ADDITIONAL INFORMATION: THE PATIENT WAS TAKEN TO THE OR FOR A CUTDOWN PROCEDURE IN ORDER TO REMOVE THE KNOTTED GUIDEWIRE. WHILE THE PATIENT WAS SEDATED, THEY ALSO PLACED A SC TLC FOR THE PATIENT TO GET CENTRAL ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21877731 ↗
• InjuryMay 2, 2024Material Frayed; Material Frayed

  IT WAS REPORTED DURING PLACEMENT OF A MIDLINE THE NURSE GAINED ACCESS UTILIZING THE 25G NEEDLE. ONCE THE VEIN WAS ACCESSED, HE ATTEMPTED TO THREAD THE FLEXURA WIRE. HE WAS UNABLE TO THREAD THE WIRE, THE NURSE REMOVED THE NEEDLE THEN THE WIRE. UPON EXAMINATION OF THE WIRE, HE NOTICED THAT A PORTION OF THE FLEXURA WIRE WAS FRACTURED. AN ULTRASOUND OF THE PATIENT¿S EXTREMITY WAS PERFORMED WHERE A FOREIGN BODY MEASURING 0.6 CM WAS IDENTIFIED IN THE SUBCUTANEOUS TISSUE OF THE LEFT UPPER ARM. RN CONFIRMED THAT IT WAS NOT IN THE VEIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19235190 ↗
• MalfunctionMar 13, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THEY NOTICED A FRAYED STYLET WIRE ON A BARD PROVENA MIDLINE CATHETER WHEN INSERTING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893388 ↗
• MalfunctionMar 13, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THEY NOTICED A FRAYED STYLET WIRE ON A BARD PROVENA MIDLINE CATHETER WHEN INSERTING. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893379 ↗
• MalfunctionFeb 15, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "THE WIRE WAS FRAYED WHEN REMOVED FROM THE PACKAGE. END USER PULLED WIRE TO TRIM AND NOTICED FRAYING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717012 ↗
• MalfunctionJul 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER GRAY SHEATH FOR THE MIDLINE WAS COMPRESSED BACK UPON INSERTION THROUGH THE SKIN LIKE AN ACCORDION. ADDITIONAL INFO RECEIVED ON (B)(6) 2023: THIS EVENT DIRECTLY INVOLVED PATIENT AND PLACER. WAS NOTICED WHEN IT WAS DIFFICULT TO INSERT. NO URGENT MEDICAL SITUATION OCCURRED AND NO ADDITIONAL HARM TO THE PATIENT. DURING ROUTINE INSERTION INTRODUCER WOULD NOT THREAD WHEN IT WAS ASSESSED AND FOUND THE ISSUE, NEW KIT OPENED TO GET INTRODUCER, LINE PLACED WITH NO ISSUES. VAT HAD AN EXTRA KIT ON THEIR CART AND WAS ABLE TO OBTAIN A NEW INTRODUCER TO COMPLETE THE PROCEDURE. ADDITIONAL COST WAS ADDED DUE TO HAVING TO OPEN ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306859 ↗
• MalfunctionJan 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "THE MICRO INTRODUCER SHEATH TO ACCORDION OR FOLD BACK UPON INSERTION THROUGH THE SKIN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088376 ↗
• MalfunctionJan 3, 2023Material Deformation; Material Deformation

  T WAS REPORTED BY THE CUSTOMER "THE MICRO INTRODUCER SHEATH ACCORDIONED OR FOLDED BACK UPON INSERTION THROUGH THE SKIN. NURSE ATTEMPTED TO PUSH PASS THE SKIN WITH MINIMAL SUCCESS AND THEN TRIED TO PULL IT OUT AFTER SLIGHTLY PENETRATING THE SKIN AND THEN FELT A SNUG REMOVAL. DEVICE WAS REMOVED SUCCESSFULLY WITH NO ISSUE. ADDITIONAL INFORMATION RECEIVED 12/16/2022: IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL ¿I WAS SET UP TO PLACE THE MIDLINE. DUE TO ISSUES, WE HAD BEEN HAVING I THOROUGHLY INSPECTED THE INTRODUCER BEFORE INSERTION. EVERYTHING LOOKED NORMAL. I DO NOT NICK BEFORE INSERTING AS MOST INSERT WITHOUT ISSUE. I WAS MEETING RESISTANCE, SO I PULLED THE INTRODUCER BACK, MADE A SLIGHT NICK AND REINSERTED. I DID NOT INSPECT THE INTRODUCER BEFORE TRYING THE SECOND TIME, BUT AS IT ENTERED THE EPIDERMIS AND THEN DERMIS, I WAS FEELING A LOT OF RESISTANCE, LIKE I WAS GOING THROUGH THE BACK OF CARPET. I PULLED THE CATHETER OUT AND THAT IS WHEN I NOTICED THAT THE GREY PART OF THE INTRODUCER HAD TWO FRAYS. ANOTHER KIT (PICC KIT) WAS OPENED, AND THE INTRODUCER USED OUT OF THAT KIT WITH NO ISSUES. DEVICE WAS SECURED WITH A STATLOCK. CATHETER IS STILL INTACT DUE TO DOCUMENTATION. NO HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088217 ↗
• MalfunctionDec 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE MICROINTRODUCER SHEATH FAILED TO INSERT PASSED THE SKIN AND FOLDED BACK OR BEGAN TO SPLIT UPON ATTEMPT TO INSERT INTO THE VEIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071016 ↗
• MalfunctionDec 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER WOULD NOT INSERT AND ADVANCE PASS THE SKIN. IT WAS STATED THE INTRODUCER BEGAN TO SPLIT OR FREY AT THE TRANSITION POINT OF THE INTRODUCER PLASTIC SHEATH. A NEW KIT WAS OPENED AND IT WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905752 ↗
• MalfunctionDec 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "THAT THE PICC INTRODUCER SHEATH WOULD NOT INSERT PASS THE SKIN AND ENDED UP SPLITTING AT THE SITE OR FREYING WHICH CAUSED CUSTOMER TO OPEN A FULL BRAND NEW KIT." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED "WHEN MY STAFF IS ATTEMPTING TO INSERT THE INTRODUCER IN THE PATIENT THEY ARE HAVING ISSUES, THEY NOTICE THE ISSUE WITH THE INTRODUCER ONCE THEY ATTEMPT. THEY HAVE MADE A LARGER NICK THINKING IT WAS THE PATIENTS SKIN BEFORE REALIZING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905094 ↗
• MalfunctionNov 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "THAT THE INTRODUCER SHEATH WOULD NOT ADVANCE PASS THE SKIN DESPITE MANY ATTEMPTS. THE SHEATH DOES DISPLAY SPLITTING AT THE TRANSITION POINT FROM THE WHITE STYLET TO THE GRAY SHEATH." ADDITIONAL INFORMATION RECEIVED: A NEW, LARGER INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO NEW VESSEL ACCESS NEEDED. CUSTOMER REPORTED MORE BLEEDING THAN USUAL DUE TO VESSEL TRAUMA FROM USING A LARGER INTRODUCER NEEDLE. THERE WAS NO DELAY IN MEDICATION AND NO NEGATIVE OUTCOME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821480 ↗
• MalfunctionOct 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "THAT THE INTRODUCER SHEATH BEGAN TO SPLIT OR FREY AT THE SKIN WHICH SIGNIFICANTLY RESTRICTED ACCESS BEYOND THE SKIN. CUSTOMER HAD TO OPEN A NEW SET IN ORDER TO PLACE THE LINE APPROPRIATELY USING A NEW INTRODUCER"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584386 ↗
• MalfunctionJun 23, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "DURING MIDLINE PLACEMENT, MICROEZ MICROINTRODUCER WITH VESSEL DILATOR INSERTED WITHOUT COMPLICATIONS INTO PTS ARM, WITH PROPER TECHNIQUE. INTRODUCER SHEATH IS MEANT TO BREAK AWAY ONCE MIDLINE CATHETER IS IN PLACE, ONE SIDE OF THE FRONT END OF SHEATH THAT IS HELD DURING BREAKAWAY PORTION SNAPPED OFF OF THE SHEATH, LEAVING THE SHEATH STILL IN PLACE, HOWEVER WITHOUT THE PORTION TO HOLD INTACT. REMAINDER OF THE SHEATH WAS ABLE TO BE REMOVED WITHOUT COMPLICATION." ADD INFO RECEIVED 06/06/2022: EXPLANT DATE: (B)(6) 2022 WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787647 ↗
• MalfunctionMar 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED MICROINTRODUCER BUCKLED WHEN TRYING TO INSERT. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2021: IT WAS FOUND THAT THE INTRODUCER SHEATH TIP WAS FLARED AND DAMAGED ON THE RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474630 ↗
• MalfunctionDec 23, 2020Defective Component; Failure to Advance

  IT WAS REPORTED A DEFECT WAS FOUND WITH AN INTRODUCER, NOT ALLOWING IT TO THREAD IN EASILY. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH "VAT NURSE PLACING A MIDLINE, UNABLE TO THREAD IN INTRODUCER, EVEN AFTER NICKING THE PATIENT, INTRODUCER REMOVED AND THAT IS WHEN THE DEFECT WAS NOTICED, A NEW MIDLINE KIT OPENED TO RETRIEVE SECOND INTRODUCER, NO ISSUES AFTER USING NEW INTRODUCER. IT WAS REPORTED THIS OCCURRED TWICE. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11065115 ↗
• MalfunctionDec 22, 2020Difficult to Insert

  IT WAS REPORTED A DEFECT WAS FOUND WITH AN INTRODUCER, NOT ALLOWING IT TO THREAD IN EASILY. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH "VAT NURSE PLACING A MIDLINE, UNABLE TO THREAD IN INTRODUCER, EVEN AFTER NICKING THE PATIENT, INTRODUCER REMOVED AND THAT IS WHEN THE DEFECT WAS NOTICED, A NEW MIDLINE KIT OPENED TO RETRIEVE SECOND INTRODUCER, NO ISSUES AFTER USING NEW INTRODUCER. IT WAS REPORTED THIS OCCURRED TWICE. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11060901 ↗