Midline Catheter Kit S4153108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741153952), received between Apr 17, 2019 and May 18, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Activation Problem

  IT WAS REPORTED BY MEDWATCH THAT THE SAFETY FEATURE SLID COMPLETELY OFF THE SHAFT OF THE BD SECURE-LOC INTRODUCER NEEDLE. IT DID NOT LOCK AND STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211620 ↗
• MalfunctionFeb 25, 2026Activation Problem

  IT WAS REPORTED WHEN INTRODUCER NEEDLE WAS BEING REMOVED, RN WENT TO SAFETY THE INTRODUCER NEEDLE AND THE SAFETY MECHANISM SLID OFF THE END OF THE NEEDLE, EXPOSING RN TO POTENTIAL FOR NEEDLESTICK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444424 ↗
• InjuryJan 8, 2026Activation Problem

  IT WAS REPORTED THAT SAFETY ON THE NEEDLE HAS POPPED OFF WHEN HE TRIES TO SAFETY THE NEEDLE AFTER USE RESULTING IN A NEEDLE STICK. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 24003012 ↗
• MalfunctionJan 8, 2026Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY ON THE NEEDLE HAS POPPED OFF WHEN HE TRIES TO SAFETY THE NEEDLE AFTER USE. NO FURTHER DETAILS AVAILABLE OR PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES ALL BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003005 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Activation Problem; Detachment of Device or Device Component; Activation Problem

  ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH: IT WAS REPORTED NURSE REMOVED THE REMAINING PORTION OF THE NEEDLE MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941823 ↗
• MalfunctionApr 14, 2025Material Separation

  WHEN REMOVING INTRODUCER NEEDLE FROM PATIENT AND ENGAGING THE SAFETY, THE GREEN SAFETY PORTION CAME APART FROM THE NEEDLE. NO INJURY TO PATIENT OR STAFF. NURSE REMOVED THE REMAINING PORTION OF THE NEEDLE MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21834488 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, LINE WAS PRIMED WITH NO OBVIOUS ISSUES. LINE WAS PLACED IN A PATIENT. WHEN THE INSERTER DREW BACK FOR BLOOD RETURN ONLY AIR CAME INTO THE SYRINGE. NEEDLELESS CONNECTOR AND SYRINGE WERE CHANGED OUT AND CONTINUED WITH AIR. MIDLINE WAS OVER WIRED TO A NEW MIDLINE AND THERE WERE NO ISSUES. ADDITIONAL INFORMATION RECEIVED 11-FEB 2025: IT WAS REPORTED NURSE NOTICED DURING INSERTION THERE WAS AN ISSUE WITH THE CATHETER. AFTER TROUBLESHOOTING WITH NO SUCCESS (CHECKING CONNECTIONS) SHE PLACED A NEW MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415577 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER; LINE WAS PLACED ON (B)(6) 2025 WITHOUT ISSUES. PATIENT CAME TO THE ER ON (B)(6) 2025 TO GET A NEW MIDLINE. HOME INFUSION RN REMOVED MIDLINE BECAUSE IT WAS LEAKING FROM THE CATHETER. ADDITIONAL INFORMATION RECEIVED ON 11-FEB 2025: IT WAS REPORTED BY THE CUSTOMER; THE PATIENT HAD BEEN DISCHARGED WITH HER LINE WITH NO COMPLICATIONS. VISITING INFUSION NURSE REMOVED THE MALFUNCTIONING MIDLINE AND SENT PATIENT TO THE EMERGENCY DEPARTMENT FOR PLACEMENT OF A NEW MIDLINE SINCE HER COURSE OF THERAPY WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415570 ↗
• MalfunctionJan 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WE HAD A MIDLINE KIT OVER THE WEEKEND HAVE A SAFETY NEEDLE ISSUE. AFTER INSERTION THE GREEN END ON THE SAFETY NEEDLE DOES NOT CAP. IT JUST SLIDES OFF INSTEAD OF PROTECTING TIP FROM POTENTIAL NEEDLE STICK INJURY TO INSERTER. THERE WAS NO HARM OR INJURY TO PATIENT OR INSERTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139480 ↗
• InjuryJan 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE PROVENA SAFETY CAP SLID OFF AND RESULTED IN ACCIDENTAL STICK. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21131811 ↗
• MalfunctionDec 29, 2024Material Deformation; Material Deformation

  IT WAS REPORTED A MICRO INTRODUCER THAT "BUCKLED/WRINKLED" WHEN THE NURSE ATTEMPTED INSERTION. THERE ARE MULTIPLE "WRINKLES" IN THE PART THAT WE USUALLY BREAK AWAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032776 ↗
• MalfunctionJul 13, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT POWERMIDLINE IS LEAKING AT THE T CONNECTOR. THEY HAVE TO MANIPULATE TO GET IT TO WORK CORRECTLY. HAD TO SPEND EXTRA TIME WORKING AROUND THE PROBLEM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321745 ↗
• MalfunctionJul 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE THROUGH THE NEEDLE, THE GUIDEWIRE BECAME LODGED WITHIN THE VESSEL. THE NURSE WAS ABLE TO REMOVE THE NEEDLE AND GUIDEWIRE ALTOGETHER, HOWEVER THE GUIDEWIRE APPEARS TO HAVE UNRAVELED APPROXIMATELY 15-20 CM FROM THE TIP. ADDITIONAL INFORMATION RECEIVED 06/26/2023: WHILE ATTEMPTING TO PLACE A MIDLINE CATHETER, THE NURSE ATTEMPTED TO REMOVE THE GUIDEWIRE THROUGH THE NEEDLE AND THE GUIDEWIRE BECAME LODGED WITHIN THE VESSEL. THE NURSE WAS ABLE TO REMOVE THE GUIDEWIRE WITH THE NEEDLE AT THE SAME TIME, HOWEVER THE GUIDEWIRE APPEARS TO HAVE UNRAVELED APPROXIMATELY 15-20CM FROM THE TIP. THE NURSE STOPPED THE PROCEDURE IMMEDIATELY AND SEGREGATED THE DEVICE. THE PHYSICIAN WAS NOTIFIED OF THE ISSUE AND AN X-RAY WAS ORDERED TO CHECK FOR ANY RETAINED PIECES OF THE DEVICE. THE X-RAY SHOWED NO EVIDENCE OF A FOREIGN BODY, AND THE PATIENT REQUIRED NO OTHER TREATMENT RELATED TO THE EVENT. THERE WAS NO ADVERSE OUTCOME FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312874 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "THE 3FR INTRODUCER IN THE PROVENA MIDLINE KIT BUNCHED UP WHEN TRYING TO ADVANCE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004404 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "RN'S HAVE TROUBLE WITH IT KINKING IN SOME CIRCUMSTANCES [WITH THE 3.5FR SHEATH IN THE PICC KIT]. " A SPECIFIC NUMBER OF AFFECTED DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765847 ↗
• MalfunctionApr 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, "I¿M STILL NOTICING THIS PROBLEM WITH THE INTRODUCERS BASICALLY BUCKLING. WHEN I TRY TO ADVANCE IT, IT DOES GO SMOOTHLY AND IT'S LIKE THE GREY PART OF THE PEEL AWAY SHEATH GETS CAUGHT ON THE SKIN AND RESISTS ADVANCING, CAUSES THE PLASTIC TO CRUMPLE UP. IT'S LIKE THE MATERIAL ISN¿T STIFF ENOUGH, BUT ALSO THE TRANSITION TO THE TAPER WHITE INNER DILATOR IS NOT SMOOTH ENOUGH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660742 ↗
• MalfunctionJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "I HAVE A 3FR MIDLINE CRACKING OPEN WHERE LINE MEETS LUER LOCK." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16109713 ↗
• MalfunctionJul 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6) 2022 ONE OF THE MEMBERS WAS PLACING A 3 FRENCH BARD PROVENA POWER INJECTABLE MIDLINE ON A PATIENT. THE NURSE HAD NO ISSUES CANNULATING THE VESSEL BUT WHEN SHE ATTEMPTED TO DILATE THE VESSEL, SHE NOTICED THAT SHE WAS MEETING RESISTANCE WITH THE INTRODUCER/DILATOR. WHEN SHE INSPECTED THE INTRODUCER/DILATOR, SHE NOTICED THAT THE SHEATH OF THE INTRODUCER WAS PEALING BACKWARDS. SHE OBTAINED ANOTHER INTRODUCER/SHEATH AND WAS ABLE TO EASILY FINISH DILATING THE VESSEL AND PLACE THE MIDLINE CATHETER. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957665 ↗
• MalfunctionMay 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "HAD A GUIDE WIRE FOR A MIDLINE GET STUCK TODAY. THE PATIENT IS NOW GOING TO IR TO SEE IF THEY CAN GET IT OUT. AS SOON AS I MET RESISTANCE, I TRIED TO PULL BACK ON THE WIRE, BUT IT WOULDN'T BUDGE. SO THEN I TRIED TO PULL THE WIRE AND NEEDLE OUT TOGETHER. THE NEEDLE CAME OUT, BUT THE WIRE STAYED IN. . . WE MEASURED, AND IT APPEARS TO BE 1.5CM THAT GOT STUCK IN THE PATIENT'S ARM." ADDITIONAL INFORMATION RECEIVED 05/13/2022: "ATTEMPTED TO PLACE MIDLINE TO LEFT BRACHIAL VEIN. VEIN ACCESSED WITHOUT DIFFICULTY, HOWEVER, RESISTANCE WAS MET WHEN INSERTING GUIDE WIRE AFTER ABOUT 10CM OF INSERTION. ATTEMPTED TO REMOVE GUIDE WIRE, BUT IT BECAME STUCK. SO AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE WITH THE NEEDLE, BUT GUIDE WIRE REMAINED STUCK. NEEDLE REMOVED SUCCESSFULLY. RN (VAT PCC) CALLED FOR ASSISTANCE. HE ALSO TRIED TO REMOVE GUIDE WIRE AS WELL, BUT WAS ALSO UNSUCCESSFUL. MEASURED EXTERNAL LENGTH OF STUCK GUIDE WIRE AND COMPARED TO AN UNUSED GUIDE WIRE, AND IT APPEARS TO BE 1.5CM THAT WAS STUCK IN PT'S ARM. DR. NOTIFIED. ORDERS RECEIVED FOR PT TO GO TO IR TO ATTEMPT GUIDE WIRE REMOVAL. REPORT CALLED TO IR. THEY STATE THEY CURRENTLY HAVE A PT ON THE TABLE. GUIDE WIRE STA

  Patient problems: Foreign Body In Patient

  MAUDE report 14465383 ↗
• MalfunctionNov 4, 2021Improper or Incorrect Procedure or Method; Difficult or Delayed Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Separation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "DURING INSERTION AND DILATION STEP WITH THE INTRODUCER/PEEL AWAY I HAVE NOTICE UNUSUAL RESISTANCE. ON OCCASIONS I REMOVE THE INNER WHITE DILATOR AND DO 2 STEP DILATION. DESPITE THIS IT FEEL THAT THE LIP/TRANSITION TO THE GREY PEEL AWAY PART IS TOO PRONOUNCED AND GETS CAUGHT OFTEN. REQUIRING MORE FORCE THAN I¿D LIKE TO USE. AND AT TIMES BUCKLES THE SHEATH. THIS PATIENT¿S SKIN WAS NOT ABNORMALLY TOUGH. I HAVE NOTICED THIS SEVERAL TIMES WITH BOTH 3.5 AND 4.5 FR DILATORS IN RECENT MONTHS. WHICH IS LEADING TO MORE SKIN KNICKS WITH SCALPEL WHICH IS HIGHLY UN-PREFERRED AND INCREASES BLEEDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754915 ↗
• MalfunctionNov 4, 2021Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "DURING INSERTION AND DILATION STEP WITH THE INTRODUCER/PEEL AWAY I HAVE NOTICE UNUSUAL RESISTANCE. ON OCCASIONS I REMOVE THE INNER WHITE DILATOR AND DO 2 STEP DILATION. DESPITE THIS IT FEEL THAT THE LIP/TRANSITION TO THE GREY PEEL AWAY PART IS TOO PRONOUNCED AND GETS CAUGHT OFTEN. REQUIRING MORE FORCE THAN I¿D LIKE TO USE.. AND AT TIMES BUCKLES THE SHEATH. THIS PATIENT¿S SKIN WAS NOT ABNORMALLY TOUGH. I HAVE NOTICED THIS SEVERAL TIMES WITH BOTH 3.5 AND 4.5 FR DILATORS IN RECENT MONTHS. WHICH IS LEADING TO MORE SKIN KNICKS WITH SCALPEL WHICH IS HIGHLY UN-PREFERRED AND INCREASES BLEEDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754906 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I AM CONTACTING YOU AGAIN REGARDING LEAKING BARD POWER MIDLINES. I KNOW IN THE PAST WE DECIDED IT IS NOT A LEAK FROM THE PRODUCT ITSELF, BUT FLUID AND BLOOD ARE LEAKING OUT AROUND THE PRODUCT FROM INSERTION SITES. IT WAS SUGGESTED TO US TO CUT THE MIDLINES SHORTER TO PREVENT POSSIBLE BACK PRESSURE OCCURRING AT THE SHOULDER JOINT. THIS SUGGESTION HAS NOT HELPED. IF I HAD TO GUESS, WE ARE REPLACING 75% OF THE MIDLINES WE PLACE FOR THIS LEAKING ISSUE." ADD INFO RCVD : MIDLINE WAS FOUND TO BE LEAKING FROM INSERTION SITE. CATHETER EXTERIOR THE BODY 0.5 CM. DRESSING CHANGE WAS ATTEMPTED EARLIER IN THE DAY. FOUND TO BE SATURATED TWO HOURS LATER. CATHETER REMOVED INTACT. NO SIGN/SYMPTOMS OF INFECTION NOTED AT INSERTION SITE. PATIENT WAS SWITCHED FROM IV ANTIBIOTICS TO ORAL FOR DISCHARGE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? 3M DRESSING STAT LOCK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530929 ↗
• MalfunctionDec 12, 2020Fluid/Blood Leak

  IT WAS REPORTED A MIDLINE WAS PLACED BY AN IMAGING SERVICES RN AND THE INFUSION CENTER FOUND THIS LINE TO BE LEAKING. THE PATIENT WAS SENT TO A DIFFERENT FACILITY FOR EVALUATION AND REPLACEMENT AS NEEDED. FOLLOWING ASSESSMENT OF THE LINE, IT WAS DETERMINED THAT A NEW MIDLINE WAS NEEDED AND PLACED BY AN IMAGING SERVICES RN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10995378 ↗
• MalfunctionNov 13, 2020Component Missing

  IT WAS REPORTED: "THE INITIAL MIDLINE WAS REMOVED DUE TO A MISSING END CAP FOUND BY THE NURSING HOME. MIDLINE WAS REPLACED WITH ANOTHER MIDLINE. SAME ARM, DIFFERENT VEIN. THE SAME ARM WAS USED FOR THE SECOND MIDLINE PLACEMENT DUE TO A LARGE SURGICAL SCAR ON THE RIGHT UPPER ARM." WHAT THEY¿RE BEING TREATED FOR:" PNEUMONIA AND WOUND NECROSIS." WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? "STAT LOCK INCLUDED IN MIDLINE KIT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10839465 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak

  IT WAS REPORTED MIDLINE FOUND LEAKING. ADDITIONAL INFORMATION RECEIVED 10/27/2020: IT WAS REPORTED THE MIDLINE WAS REMOVED DUE TO LEAKING FROM THE INSERTION SITE. IT WAS STATED THE HEALTHCARE PROFESSIONALS ARE UNSURE IF THE LEAKAGE WAS FROM THE PATIENT'S DELICATE, BOGGY SKIN OR IF IT IS A PRODUCT ISSUE. THE LINE WAS REPLACED WITH A PICC LINE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10838678 ↗