Per-Q-Cath Plus Catheter 4135115Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741074929), received between Nov 30, 2017 and Jul 16, 2021 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

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.

• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JUNE 3TH, THE PATIENT HAD REPEATED PAIN ON THE INNER SIDE OF THE RIGHT UPPER ARM AND THROMBOSIS AT THE TIP OF THE CATHETER DURING THE USE OF THE CENTRAL VENOUS CATHETER. DO NOT PULL OUT THE PICC CATHETER TO PREVENT THE THROMBUS FROM FALLING OFF. SUSPEND THE INFUSION FROM THE PICC AND ANTICOAGULANT THERAPY.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 12182111 ↗
• MalfunctionJan 29, 2021Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE CATHETER HAS BEEN USING FOR 15 DAYS, A NURSE FOUND SEEPAGE BENEATH DRESSING WHEN PERFORMING INFUSION USING THE CATHETER. UPON DISCOVERING THE LEAKS, THE NURSE REMOVED THE CATHETER AND OBSERVED FOR DAMAGE. WHEN ROTATED, THE CATHETER RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11254709 ↗
• MalfunctionJan 29, 2021Break; Break; Material Rupture

  IT WAS REPORTED THAT ON DAY 3 POST CATHETER PLACEMENT, A NURSE FOUND SEEPAGE BENEATH DRESSING WHEN PERFORMING INFUSION USING THE CATHETER. AFTER UNCOVERING THE DRESSING, THE NURSE FOUND THAT THE CATHETER RUPTURED AT THE ROOT AND REMOVED THE CATHETER

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

  MAUDE report 11253175 ↗
• MalfunctionMay 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2020 DUE TO CEREBRAL HERNIA AS A RESULT OF HEAD INJURY. AT 15:00, CATHETER PLACEMENT WAS PERFORMED, WITH 37 CM PLACED INTERNALLY AND ANOTHER 6 CM EXPOSED EXTERNALLY. AT 9:00, (B)(6), A NURSE OBSERVED RUPTURE AT JOINT BETWEEN CATHETER AND FITTING (RUPTURE EXTERNALLY).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026961 ↗
• MalfunctionApr 7, 2020Break; Break

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO GENERAL ICU DUE TO SUBARACHNOID HEMORRHAGE FROM RUPTURE OF ANTERIOR COMMUNICATION ANEURYSM ON (B)(6) 2020. ON (B)(6) , A PQC CATHETER WAS PLACED FROM THE LEFT BASILIC VEIN UNDER THE GUIDANCE OF ULTRASOUND USING THE SELDINGER TECHNIQUE DUE TO THE NEED OF LIQUID TREATMENT. 37 CM OF THE CATHETER WAS INSERTED WITH ANOTHER 5CM EXPOSED EXTERNALLY. THE PUNCTURE SUCCEEDED ONLY BY ONE TIME AND THE CATHETERIZATION WENT SMOOTHLY. ON (B)(6) , THIS PATIENT MOVED THE ARM AS ELEVATING THE BED FOR LUNCH, AND FOUND THAT THE CATHETER RUPTURED, NOTIFIED THE NURSE IMMEDIATELY. CATHETER REMOVAL WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933493 ↗
• MalfunctionApr 7, 2020Break; Break

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO NICU DUE TO "CAUSE OF COMA TO BE INVESTIGATED" ON (B)(6) 2020. BECAUSE OF THE NEED OF LIQUID TREATMENT, A PQC CATHETER WAS PLACED FROM THE RIGHT BASILIC VEIN UNDER THE GUIDANCE OF ULTRASOUND USING THE SELDINGER TECHNIQUE ON (B)(6). 35 CM OF THE CATHETER WAS INSERTED WITH ANOTHER 3CM EXPOSED EXTERNALLY. THE PUNCTURE SUCCEEDED BY ONE TIME AND THE CATHETERIZATION WENT SMOOTHLY. ON FEBRUARY 1, THE CATHETER WAS FOUND TO BE DETACHED AND RUPTURED AT THE 0.5 CM MARK OUTSIDE THE 0 CM MARK. CATHETER WITHDRAWAL WAS PERFORMED IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933246 ↗
• MalfunctionNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT FROM THE NEUROLOGY DEPARTMENT UNDERWENT MIDLINE CATHETER WITHDRAWAL AFTER THE TREATMENT WAS COMPLETED. DURING THE EXAMINATION OF THE CATHETER INTEGRITY, A RUPTURE WAS FOUND IN THE TIP OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267107 ↗
• MalfunctionJun 12, 2019Break; Break; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE "PATIENT UNDERWENT BLIND CATHETER PLACEMENT ON APRIL 29, 2019 TO TREAT THE TUBERCULAR MENINGITIS THROUGH THE INFUSION OF A LARGE AMOUNT OF MANNITOL, CONCENTRATED POTASSIUM AND SODIUM. FOLLOWING SUCCESSFUL PUNCTURE, THE CATHETER WAS DELIVERED TO THE TARGET POSITION, WITH 39 CM OF IT REMAINING IN THE BODY AND ANOTHER 14 CM EXPOSED OUTSIDE. AT 7:15 AM ON (B)(6) IT WAS FOUND THAT THE PATIENT'S SHEET WAS WETTED AND NOTIFIED HIS/HER FAMILY AND NURSE. UPON EXAMINATION, THE NURSE FOUND THE PICC TUBING RUPTURED AT THE ROOT AND THE TWO PARTS WERE SEPARATED FROM EACH OTHER. IMMEDIATELY NOTIFIED A SURGEON AND REMOVED THE CATHETER FOLLOWING THE SURGEON'S ADVICE. PRESSED THE PUNCTURE SITE, AND LET THE PATIENT LIE IN A POSITION, WITH THE LEFT HEAD LOWER WHILE THE FEET HIGHER, INHALED OXYGEN, MEASURED BLOOD PRESSURE, LET PATIENT KEEP AT REST IN BED. PATIENT IN STABLE CONDITION AND CONTINUED TREATMENT IN HOSPITAL."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8692825 ↗
• MalfunctionAug 29, 2018Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHEN THE CATHETER WAS UNPACKED FOR USE, AFTER CONFIRMING THE RESERVED LENGTH, THE GUIDE WIRE WAS WITHDRAWN, AND WRINKLE WAS FOUND AT THE 0 SCALE OF THE CATHETER, AND THE 0 SCALE WAS FOUND BROKEN AFTER RE-FLUSHING THE CATHETER.

  Patient problems: No Information

  MAUDE report 7827210 ↗
• MalfunctionAug 2, 2018Break; Fracture

  IT WAS REPORTED THAT A FRACTURE WAS FOUND AT THE 0 MARK WHEN PRE-RINSING THE CATHETER. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7745265 ↗
• MalfunctionNov 30, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE PATIENT'S BLOOD WAS DRAWN A MILKY LIQUID WAS PRESENT. THE AMOUNT OF THE LIQUID WAS SIGNIFICANTLY REDUCED AFTER DRAWING 20ML. ¿THE CATHETER WAS REMOVED ON THE SAME DAY AND THERE WAS STILL SOME MILKY LIQUID WITHIN THE LUMEN WHICH CAN BE PRECIPITATED.¿ NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070699 ↗