Per-Q-Cath Plus Catheter 4134115Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00801741074899), received between Sep 13, 2017 and Jan 27, 2022 — classified as 3 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (58 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER THE PACKAGE WAS OPENED, THE CUSTOMER FOUND THAT THE GUIDE WIRE HAD BEEN PULLED OUT. (B)(6) 2022: THE RETURNED STYLET WAS FOUND UNRAVELED AND ELONGATED WITH MULTIPLE BENDS AND HAD TANGLED UPON ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13373928 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DUE TO THE NEED FOR CHEMOTHERAPY, A PERIPHERALLY INTUBATED CENTRAL VENOUS CATHETER WAS USED TO INSERT THE CENTRAL VENOUS CATHETER FROM THE RIGHT UPPER EXTREMITY INTO THE SUPERIOR VENA CAVA UNDER THE GUIDANCE OF B-ULTRASOUND FOR INTRAVENOUS INFUSION OF DRUGS TO PREVENT EXTRAVASATION OF CHEMOTHERAPY DRUGS. AFTER THE CATHETER IS PLACED, THE CATHETER SHOULD BE STERILIZED, CHANGED, AND CLEANED EVERY WEEK FOR MAINTENANCE. FOR CHEMOTHERAPY: 2 CYCLES OF ENDOSTATIN THERAPY ON (B)(6) 2021 AND (B)(6) 2021, 2 CYCLES OF CHEMOTHERAPY STARTING ON (B)(6) 2021, AND (B)(6) 2021, THE SPECIFIC DOSE IS: MORE SITAXEL + CARBOPLATIN. FOR THE TREATMENT OF LUNG CANCER. ON (B)(6) 2021, HE WAS RETURNED TO THE HOSPITAL AND THE PATIENT COMPLAINED OF SWELLING, PAIN AND DISCOMFORT IN THE RIGHT UPPER ARM. THE B-ULTRASOUND OF THE RIGHT UPPER EXTREMITY VEIN SHOWED THROMBOSIS OF THE RIGHT SUBCLAVIAN VEIN INDWELLING TUBE. AFTER CONSULTATION WITH VASCULAR SURGERY, ORAL RIVAROXABAN 10 MG WAS ADDED ON (B)(6) 2021, ONCE A DAY FOR ANTICOAGULATION.

  Patient problems: Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 13373043 ↗
• MalfunctionDec 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PLACING THE PQC, THE CUSTOMER PRE-FLUSHED THE CATHETER AND FOUND A SAND-HOLE NEAR THE DISTAL END OF THE CATHETER. WHEN PRE-FLUSHING THE CATHETER, LIQUIDS WERE SEEN LEAKING FROM THE SAND-HOLE. UPON RECEIPT OF THE FEEDBACK FROM THE CUSTOMER, WE HAVE LEARNED ABOUT THE RELEVANT INFORMATION OF THE CATHETER AND INQUIRED AND OBSERVED THE OPERATION DETAILS BY THE CATHETER PLACEMENT OPERATOR. IT WAS STATED THAT THERE WAS NO ISSUE OF IMPROPER PLACEMENT OF SHARP INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078721 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PRE-FLUSHING THE CATHETER PRIOR TO PLACEMENT, THE CATHETER PLACEMENT OPERATOR FOUND THAT THE CATHETER LEAKED WATER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410795 ↗
• MalfunctionAug 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PLACING THE CATHETER, THE CLINICAL HEAD NURSE FOUND THAT THE PROXIMAL END OF THE CATHETER LEAKED LIQUID. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389149 ↗
• MalfunctionAug 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT FOUND THAT THE CATHETER COMPLETELY RUPTURED AT THE CONNECTOR THE FOLLOWING DAY AFTER PLACEMENT. THE NURSE WAS TOLD AND JUDGED THAT IT WAS UNUSABLE. THE CATHETER WAS THEREFORE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366395 ↗
• MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF THE CATHETER WAS COMPLETED, THE OPERATOR FOUND THE EXTENSION TUBING WAS DAMAGED WHEN FLUSHING AND CLOSING THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363447 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO HOSPITAL DUE TO CEREBRAL INFARCTION AND HAD A PQC CATHETER PLACED DUE TO THE NEED FOR SHORT- AND MID-TERM IV INFUSION OF DRUGS. DURING WARD ROUNDS ON (B)(6) 2021, THE NURSE FOUND THAT THE CATHETER WAS RUPTURED AT THE 0 SCALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12255266 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT WHEN MAINTAINING THE CATHETER 7 DAY AFTER PLACEMENT IN THIS PATIENT, THE NURSE UNCOVERED THE DRESSING AND FOUND THAT THE CATHETER RUPTURED AT THE ROOT. THE HEAD NURSE EXAMINED THE CATHETER AND REMOVED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050224 ↗
• MalfunctionMay 21, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO HOSPITAL DUE TO CEREBRAL HEMORRHAGE ON (B)(6) 2021. WITH BOTH UPPER LIMBS UNABLE TO MOVE, THE PATIENT NEEDED MID- AND LONG-TERM INFUSION AND A 4134115 CATHETER WAS PLACED. DURING MEDICAL STAFF SHIFT ON (B)(6) 2021, THE CATHETER WAS FOUND RUPTURED AT THE SCALE OF 0. THE CATHETER WAS THUS REMOVED AND ANOTHER 4134115 CATHETER WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863265 ↗
• MalfunctionMay 13, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO HOSPITAL DUE TO PULMONARY NODULES AND UNDERWENT BLIND PLACEMENT OF A PQC CATHETER FROM THE RIGHT BASILIC VEIN ON APRIL 14. AFTER PROCEDURE, THE PATIENT WAS TRANSFERRED TO ICU FOR TREATMENT. WHEN EVALUATING THE CATHETER ON (B)(6), THE OPERATOR FOUND THAT THE CATHETER RUPTURED FROM THE SCALE OF ZERO. AND AN ALL-IN-ONE EXTENSION TUBE WAS CONNECTED TO THE RUPTURED PORTION IMMEDIATELY. THE USE OF THE CATHETER CONTINUED. THE NURSE WORRIED THAT POTENTIAL ADVERSE INFLUENCES WOULD BE CAUSED TO THE PATIENT AND THE ENTIRE DEPARTMENT IF THE CATHETER RUPTURE FAILED TO BE DISCOVERED TIMELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821375 ↗
• MalfunctionMay 12, 2021Component Incompatible; Component Incompatible

  IT WAS REPORTED THE ALL-IN-ONE EXTENSION TUBE DID NOT MATCH THE PQC TOTALLY AND THERE IS STILL BE A RISK OF FLUID LEAKS IN THE FUTURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813526 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THIS HOSPITAL DUE TO GLIOMA FOR SURGICAL TREATMENT. DUE TO THE LONG TREATMENT DURATION AND THE NEED FOR INFUSING DRUGS LIKE MANNITOL, IT WAS EXPECTED TO PLACE A PQC CATHETER UNDER ULTRASOUND FROM THE RIGHT BASILIC VEIN USING SELDINGER TECHNIQUE ON (B)(6). OPENED THE CATHETER AND CHECKED FOR INTEGRITY BY PRE-FLUSHING THE CATHETER, FINDING THAT IT LEAKED LIQUIDS AT THE SCALE OF 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791457 ↗
• MalfunctionApr 30, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) THE CATHETER WAS PLACED IN THIS PATIENT, WITH 5 CM EXPOSED EXTERNALLY AND SECURED WITH STATLOCK. ON (B)(6), DRESSING MAINTENANCE WAS CARRIED OUT. IN THE MORNING OF (B)(6), THE NURSE FOUND THAT THE CATHETER RUPTURED AT THE SCALE OF "0" BENEATH THE TRANSPARENT DRESSING WHEN CONDUCTING INFUSION. FORTUNATELY, THE PORTION OF THE CATHETER INSIDE THE PATIENT HAS BEEN REMOVED TIMELY. WHEN DISCOVERED, THE DRESSING WAS SUBSTANTIALLY COMPLETE AND EXTERNAL FACTORS SUCH AS PATIENT CAN BE RULED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755546 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT UNDERWENT PICC PUNCTURE OF THE MEDIAN VEIN OF THE LEFT ELBOW ON (B)(6) 2020, AND ROUTINE POSTOPERATIVE CARE. AT 16:30 ON (B)(6) THE PICC WAS CHANGED AT THE BEDSIDE, STERILE DRESSING WAS REPLACED AFTER DISINFECTION, AND 20ML OF NORMAL SALINE WAS GIVEN. IMPULSE SEALING OF THE TUBE, WATER SEEPAGE IN THE ATTACHMENT OF THE CATHETER JOINT, REPORT TO THE HEAD NURSE, PULL OUT, THE EXTUBATION IS SMOOTH, NO THROMBUS IS SEEN, THE PIPELINE IS INTACT, PRESS THE PUNCTURE POINT UNDER PRESSURE FOR 20 MINUTES, THE STERILE DRESSING COVERS THE PUNCTURE POINT, THE PATIENT DID NOT COMPLAIN UNWELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724297 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER 15 DAYS OF USAGE, THE CATHETER EXPERIENCED SEEPAGE. UPON DISCOVERING THE LEAKS, THE NURSE REMOVED THE CATHETER AND OBSERVED FOR DAMAGED. WHEN ROTATED, THE CATHETER RUPTURED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713656 ↗
• MalfunctionApr 23, 2021Crack; Crack

  IT WAS REPORTED THAT THE PRODUCT WAS OPENED AND CHECKED BEFORE OPERATION. CRACKS WERE NOTED WITH THE BODY OF THE INTRODUCER NEEDLE. THE PRODUCT WAS UNUSABLE. (B)(6) 2021 THE RETURNED DEVICE WAS FOUND SPLIT DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713545 ↗
• MalfunctionApr 9, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED DURING THE INTERMITTENT PERIOD OF CHEMOTHERAPY, THE PATIENT'S TUBING RETURNED BLOOD EVERY DAY, CAUSING THE TUBING TO BE BLOCKED. AT 4 PM ON (B)(6) 2021, THE PATIENT CAME TO THE HOSPITAL FOR ROUTINE MEMBRANE REPLACEMENT AND FOUND THAT THE LUMEN WAS BLOCKED. AT 4:10, THE TUBE WAS FLUSHED WITH HEPARIN SALINE, WHICH WAS UNSUCCESSFUL. AFTER COMMUNICATING WITH THE HEAD NURSE OF THE NAIL BREAST SURGERY DEPARTMENT, HE RETURNED TO THE WARD TO FLUSH THE TUBE WITH UROKINASE. RUSH AWAY AFTER 10 O'CLOCK IN THE EVENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644982 ↗
• MalfunctionApr 9, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED PATIENTS USE PICC CATHETERS FOR CHEMOTHERAPY, AND MAINTENANCE IS PERFORMED ONCE A WEEK. DURING MAINTENANCE IN THE OUTPATIENT OPERATING ROOM AT 10 AM ON (B)(6) 2021, BLOOD RETURNING FROM THE PIPELINE WAS FOUND AT 10:03, CAUSING BLOCKAGE OF THE UTERINE CAVITY. AFTER COMMUNICATING WITH THE HEAD NURSE OF THE NAIL BREAST SURGERY DEPARTMENT AT 10:05, THE PATIENT RETURNED TO THE WARD WITH UROKINASE THROMBOLYSIS AND FLUSHING. THE FLUSHING WAS SUCCESSFUL AT 6:10 PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644886 ↗
• MalfunctionMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PQC CATHETER WAS PRE-FLUSHED IN THE PROCESS OF PLACEMENT ON (B)(6) 2021, FLUIDS WERE SEEN LEAKING FROM THE 0 SCALE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423223 ↗
• MalfunctionMar 5, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS CATHETER WAS PLACED IN THIS PATIENT ON JANUARY 21, 2021. THE CATHETER RUPTURED ON FEBRUARY 6. THE CONDITIONS OF THE PATIENT WERE IN STABLE STATE. THERE IS NO APPROPRIATE ACCESS AVAILABLE FOR INFUSION CURRENTLY DUE TO THE CATHETER RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423051 ↗
• MalfunctionMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CATHETER FLUSHING AND CHECK PRIOR TO PLACEMENT, NEUROSURGERY DEPARTMENT FOUND THE CATHETER LEAKED FLUIDS FROM THE SITE ABOUT 1 CM BENEATH THE WINGED PART. THE CATHETER WAS DISCONTINUED BEING USED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423049 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "ON (B)(6) 2020, PATIENTS WITH APPENDIX CANCER IN THE SECOND AREA OF THE TUMOR USED A PERIPHERALLY INTUBATED CENTRAL VENOUS CATHETER FROM THE UPPER RIGHT LIMB TO THE SUPERIOR VENA CAVA USING A PERIPHERALLY INTUBATED CENTRAL VENOUS CATHETER FOR INTRAVENOUS INFUSION OF DRUGS TO PREVENT EXTRAVASATION OF CHEMOTHERAPY DRUGS . AFTER THE CATHETER IS INSERTED, THE CATHETER SHOULD BE DISINFECTED AND CHANGED EVERY WEEK, AND THE TUBE FLUSHED FOR MAINTENANCE. FOR CHEMOTHERAPY: ON (B)(6) 2020, (B)(6) 2020, (B)(6) 2020, (B)(6) 2020, INTRAVENOUS INFUSION OF OXALIPLATIN + ORAL CAPECITABINE CHEMOTHERAPY. USED TO TREAT MALIGNANT TUMORS OF THE APPENDIX. HE RETURNED TO THE HOSPITAL ON (B)(6) 2021, AND THE PATIENT COMPLAINED OF SWELLING AND PAIN IN HIS RIGHT UPPER ARM. THEN, A B-ULTRASOUND EXAMINATION OF THE RIGHT UPPER LIMB VEIN (B)(6) 2021, EXAMINATION NUMBER: 2581783) SHOWED THAT MURAL THROMBOSIS WAS SEEN AT THE END OF THE INDWELLING TUBE AFTER THE INDWELLING TUBE IN THE RIGHT SIDE OF THE MAIN VEIN, AXILLARY VEIN, AND SUBCLAVIAN VEIN. STARTING FROM (B)(6) 2021, LOW MOLECULAR WEIGHT HEPARIN CALCIUM 5000IU FOR INJECTION, ONCE EVERY 12 HOURS, SUBCUTANEOUS INJECTION OF ANTICOAGULANT THE

  Patient problems: Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11398539 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THIS PATIENT FROM RESPIRATORY DEPARTMENT HAD A PQC CATHETER PLACED UNDER ULTRASOUND ON (B)(6) 2020. 38 CM OF THE CATHETER WAS PLACED IN THE BODY, AND ANOTHER 7 CM OF THE CATHETER WAS EXPOSED EXTERNALLY. FLUID LEAKS OCCURRED WHEN INFUSION WAS CONDUCTED. ON (B)(6) 2021, THE PROBLEM PERSISTED. CONSULTATIONS BY CATHETER PLACEMENT CLINIC FOUND THAT THE CATHETER LEAKED FLUIDS AT THE 1 CM SCALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388691 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER ((B)(4)) IN PATIENT FROM NEUROSURGERY DEPARTMENT LEAKED FLUIDS FROM THE PORTION 1.5 CM BENEATH THE WING THREE DAYS AFTER THE PLACEMENT. DURING CATHETER FLUSHING, THE FLUIDS SPOUTED FROM THE CATHETER AND BLOOD COULD NOT BE DRAWN. NORMAL INFUSION AND BLOOD DRAWS COULD NOT BE PERFORMED WITH THE CATHETER. THEREFORE, A NEW CATHETER WAS PLACED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386597 ↗