Midline Catheter Kit S4153108DGPRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741154027), received between Mar 22, 2019 and Mar 30, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Deformation

  IT WAS REPORTED THAT 3 FR MIDLINE FAILED WITH THE DILATOR AND WAS SAVED. THE DILATOR PORTION BUNCHED UP ON THE END AND CUSTOMER HAD TO GRAB MST KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712076 ↗
• MalfunctionJun 24, 2025Activation Problem; Activation Problem

  THE CUSTOMER RETURNED AN ADDITIONAL 21G SECURELOC INTRODUCER NEEDLE FOR EVALUATION AND THE SAFETY MECHANISM IS NOT ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319172 ↗
• MalfunctionMar 14, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT SAFETY ALL THE WAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607511 ↗
• MalfunctionMar 7, 2025Activation Problem; Activation Problem

  IT WAS REPORTED INTRODUCER NEEDLE DID NOT SAFETY AFTER BEING USED FOR MIDLINE INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548875 ↗
• MalfunctionOct 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT HAS INTRODUCER, SHEATH WOULD NOT WORK. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED. 09/25/2024 IT WAS FOUND DURING AN INVESTIGATION THE PEEL-APART SHEATH EXHIBITED DEFORMATION THAT WAS CONSISTENT WITH RESISTANCE ENCOUNTERED DURING ATTEMPTED INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20489280 ↗
• InjuryJul 1, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED VIA MEDWATCH THAT ACCESS TO VEIN OBTAINED, INSERTED WIRE THROUGH CATHETER, PULLED CATHETER OUT. ADVANCED WIRE AND PATIENT COMPLAINED OF PAIN, PULLED WIRE BACK. HEALTHCARE PROVIDER WAS ABLE TO PULL WIRE BACK A FEW CENTIMETERS, AND THEN IT WAS STUCK WITH RESISTANCE FELT. PATIENT REQUIRED INTERVENTIONAL RADIOLOGY (IR) INTERVENTION FOR REMOVAL. MIDLINE WAS PLACED IN LEFT UPPER ARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19650977 ↗
• MalfunctionJun 11, 2024

  ACCESS TO VEIN OBTAINED, INSERTED WIRE THROUGH CATHETER, PULLED CATHETER OUT. ADVANCED WIRE AND PATIENT COMPLAINED OF PAIN, PULLED WIRE BACK. HEALTHCARE PROVIDER WAS ABLE TO PULL WIRE BACK A FEW CENTIMETERS, AND THEN IT WAS STUCK WITH RESISTANCE FELT. PATIENT REQUIRED INTERVENTIONAL RADIOLOGY (IR) INTERVENTION FOR REMOVAL.

  Patient problems: Pain

  MAUDE report 19515269 ↗
• MalfunctionOct 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT THE T-CONNECTOR ON THE PICC LINE THEY USED YESTERDAY. LEAKING FROM STOPPER NOTED WHILE THE PICC WAS BEING FLUSHED DURING THE INSERTION PROCESS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916919 ↗
• MalfunctionOct 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT THE T CONNECTOR ON THE PICC LINES THEY USED YESTERDAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916075 ↗
• MalfunctionMar 28, 2023Suction Problem; Suction Problem

  IT WAS REPORTED VIA MS&S: CALLER STATES SHE IS WORKING WITH A PATIENT THAT HAS POWERPICC S4153108DGP (LOT NUMBER REGY0370) AND CAN FLUSH INTO THE PICC EASILY BUT CANNOT GET A BLOOD RETURN. CALLER ASKING IF WE CAN PROVIDE CATHFLO TO HELP WITH THE OCCLUSION AND HOW TO ADMINISTER CATHFLO. MS&S RESPONSE: EXPLAINED THAT A FIBRIN TAIL CAN FORM NEAR THE TOP OF THE CATHETER. WHEN THE PICC IS FLUSHED WITH SALINE THE FIBRIN TAIL IS NOT AN ISSUE. WHEN ASPIRATED FOR A BLOOD RETURN THE FIBRIN TAIL CAN BE DRAWN INTO THE CATHETER TIP OCCLUDING THE LUMEN. CONFIRMED THE CATHFLO CAN BE USED TO HELP ALLEVIATE OCCLUSIONS CAUSED BY FIBRIN TAILS. EXPLAINED SHE WOULD NEED TO FOLLOW THE INSTRUCTIONS FOR CATHFLO USAGE. EXPLAINED THAT BD DOES NOT PROVIDE CATHFLO TO CUSTOMERS. SUGGESTED SHE CALL THE DOCTOR AND DISCUSS FURTHER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16632675 ↗
• MalfunctionMar 5, 2021Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED "WHEN GETTING READY TO DILATE, RN SEPARATED THE INTRODUCER TO MICRO-DILATE AS MANY CLINICIANS DO WITH THE 3FR PROVENA MIDLINES SINCE THE DILATE IS FLIMSY. THE DILATOR (INTERNAL LIGHTER GREY PORTION) WAS INSERTED INTO THE VEIN WITH EASE. THEN IT WAS REMOVED AND REASSEMBLED TO THE INTRODUCER/PEEL AWAY PORTION. WHILE TRYING TO ADVANCE EXTREME RESISTANCE WAS MET. RN REMOVED THE DILATOR TO FIND THAT AT THE PORTION WHERE THE DILATOR TRANSITIONS TO THE INTRODUCER, THE DARK GREY TIP OF THE INTRODUCER WAS ROLLING BACK ON ITSELF, WHICH WE SOMETIMES REFER TO AS ¿FISH MOUTH.¿ A 2ND BARD INTRODUCER WAS USED WITH NO ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11425357 ↗
• MalfunctionSep 3, 2020Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SEAL ON THE KIT WAS OPENED. IT WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10491536 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak

  IT WAS REPORTED LEAKING ON THE EXTERIOR TUBING AROUND THE HUB AND/OR AT THE HUB WAS NOTICED ON 2 CATHETERS IN THIS LOT. PICC WAS PLACED IN THE BASILIC VEIN AND NO PATIENT HARM WAS REPORTED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552278 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak

  IT WAS REPORTED LEAKING ON THE EXTERIOR TUBING AROUND THE HUB AND/OR AT THE HUB WAS NOTICED ON 2 CATHETERS IN THIS LOT. PICC WAS PLACED IN THE BASILIC VEIN AND NO PATIENT HARM WAS REPORTED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552277 ↗
• MalfunctionMar 22, 2019Leak/Splash

  IT WAS REPORTED THAT THE POWERMIDLINE WAS LEAKING AT THE SITE WHEN FLUSHING OR INFUSING. THE MIDLINE WAS TRIMMED AT 10CM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445299 ↗