Per-Q-Cath Plus Catheter 4132105Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00801741074837), received between Nov 2, 2015 and Aug 29, 2024 — classified as 4 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (127 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 262 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED CATHETER BROKE WHEN HANDLED BEFORE INSERTION INTO PATIENT. THERE WAS NO HARM TO THE PATIENT, THE MATERIAL SHOWED A QUALITY DEVIATION BEFORE BEING IMPLANTED IN THE PATIENT. PARTIAL BREAK. NO DELAY IN TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093162 ↗
• MalfunctionNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN WATERPROOFING THE CATHETER, IT IS NOTED THAT IT HAS A HOLE. NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103583 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WHEN PERFORMING THE INSERTION AND PREPARATION OF THE PICC INSERTION TECHNIQUE, THE TEST WAS CARRIED OUT AND IT WAS OBSERVED THAT IT WAS PERFORATED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708913 ↗
• MalfunctionJul 26, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER, "INSIDE THE PACKAGING OF THE CATHETER IS A STRAND OF HAIR". ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER 7/21/2023: "THE PRODUCT IS NOT DAMAGED, THE PACKAGING IS NOT TORN, THE HAIR IS INSIDE THE PACKAGING, WHICH IS SEALED. YOU CAN SEE IT THROUGH THE PLASTIC".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399040 ↗
• MalfunctionMar 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CENTRAL VENOUS ACCESS CATHETER CAME WITH HOLES SO IT WAS NOT USED IN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475440 ↗
• MalfunctionFeb 3, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CLINICIAN THAT "THE PRODUCT BROKE IN THE BUTTERFLY DURING HANDLING TO CARRY OUT THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294774 ↗
• InjuryDec 23, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH "ONE WEEK OLD NEONATE IN THE NICU HAD A PICC LINE PLACED. ON (B)(6) 2022, PICC LINE WAS ORDERED TO BE PULLED BACK 3CMS. INFANT DRESSING REMOVED PER PROTOCOL USING DRESSING CHANGE KIT AND WEARING STERILE GLOVES, HAT, MASK, AND GOGGLES. UPON REMOVAL OF TEGADERM, THE LINE APPEARED INTACT, BUT WHEN REMOVING WHITE HUB GUARD NEAR INSERTION SITE LINE FOUND TO BE IN TWO PIECES AROUND THE 4 CM MARK. PART OF LINE STILL ATTACHED TO HUB GUARD AND PART OF LINE WAS FREE. LINE GRABBED WITH TWEEZERS AND SLOWLY REMOVED. FULL LENGTH OF CATHETER ACCOUNTED FOR UPON REMOVAL. SECOND PICC NURSE TO BEDSIDE TO ASSESS. MEDICAL TEAM MADE AWARE OF FINDINGS. ORDERED PIV TO BE INSERTED AND DOSE OF VANCOMYCIN GIVEN. NEW PICC LINE TO BE INSERTED LATER THAT DAY." ADDITIONAL INFORMATION RECEIVED 12/09/2022: PATIENT REQUIRED ADDITIONAL PROCEDURE FOR NEW LINE PLACEMENT. PATIENT IS A PREEMIE AND BEING TREATED FOR GENETIC AND CARDIAC D/O, NO INFECTIOUS DISEASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16044722 ↗
• MalfunctionDec 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO PICCS PRESENTING HOLE IN ITS EXTENSION. 12/06/2022 ADDITIONAL INFORMATION: IT WAS REPORTED TWO PRODUCTS FROM THE SAME BATCH HAD THE SAME DEFECT. BOTH PRODUCTS WERE USED ON THE SAME PATIENT. THERE WAS A FIRST ATTEMPT TO INSERT "THE" PICC IN THE PATIENT, DURING THE PROCEDURE, A HOLE WAS DETECTED. THE PRODUCT HAS BEEN REMOVED. A NEW PRODUCT FROM THE SAME BATCH WAS OPENED, TESTED AND A NEW ATTEMPT WAS MADE TO INSERT INTO THE PATIENT. DURING THE PROCEDURE A HOLE WAS DETECTED. THERE WAS EXPOSURE OF THE PATIENT SINCE TWO ATTEMPTS WERE MADE TO INSERT THE CATHETER, REQUIRING A NEW APPROACH ON ANOTHER DAY TO INSERT THE DEVICE. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION, NO EXPOSURE TO BLOOD OR CHEMOTHERAPY. THIS REPORT ADDRESSES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965065 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE NURSE PERFORMED THE INSERTION OF THE PICC AND AT THE END OF THE PROCEDURE, AT THE TIME OF THE FLOW AND REFLUX TEST, WHEN SHE INFUSED THE 0.9% SALINE SOLUTION USING A 10 ML SYRINGE, IT WAS OBSERVED THAT THE CATHETER WAS LEAKING, AS THERE WAS A HOLE IN IT. THE LEAKING PICC WAS REMOVED AND A NEW PICC WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504576 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT USING PICC FOR PARENTERAL NUTRITION INFUSION, INSERTED ON (B)(6)2022. ON (B)(6) 2022, THE NURSE OBSERVED THAT THE DRESSING THAT OCCLUDED THE PICC WAS WET. WHEN REMOVING THE DRESSING AND INJECTING SALINE SOLUTION INTO THE CATHETER, WITH A 10 ML SYRINGE, SHE OBSERVED A LEAKING HOLE IN THE DISTAL PORTION OF THE CATHETER, BETWEEN THE FIRST AND SECOND FINAL CENTIMETERS. THE PICC WAS REMOVED AND ANOTHER PICC WAS INSERTED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504124 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE END OF THE DEVICE PLACEMENT PROCEDURE, WHEN IT WAS BEING TESTED FOR FLOW AND REFLOW, 0.9% SALINE SOLUTION WAS INFUSED USING A 10ML SYRINGE, IT WAS OBSERVED THAT THE CATHETER WAS LEAKING DUE TO A HOLE IN IT. IT WAS STATED THE PICC WITH LEAKAGE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421494 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT WITH PICC PLACED FOR PARENTERAL NUTRITION INFUSION. DEVICE PLACED ON (B)(6) 2022. ON (B)(6) 2022, THE NURSE OBSERVED THAT THE BANDAGE THAT COVERS THE PICC WAS WET. THE BANDAGE WAS REMOVED AND SALINE SOLUTION WAS INFUSED THROUGH CATHETER WITH A 10ML SYRINGE, THEN IT WAS NOTICED A HOLE WITH LEAKAGE IN CATHETER'S DISTAL PART, BETWEEN THE 1ST AND 2ND END CENTIMETERS. THE DEVICE WAS REMOVED AND A NEW PICC WAS PLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421117 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER INSERTION OF THE PICC IN A PATIENT, THE NURSE TESTED THE FLOW AND REFLUX OF THE CATHETER WITH 0.9% SALINE SOLUTION IN A 10 ML SYRINGE, AND NOTICED THAT THERE WAS LEAKAGE THROUGH A HOLE IN THE CATHETER. REMOVED THE CATHETER. AN ATTEMPT WAS MADE TO INSERT A NEW PICC, WITHOUT SUCCESS. THE PATIENT HAD TO BE SUBMITTED TO A CENTRAL ACCESS CATHETER PLACEMENT BY SUBCLAVIAN PUNCTURE BY A PEDIATRIC SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419682 ↗
• MalfunctionAug 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "HOLE IN CATHETER NEAR 3CM MARK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303632 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR TEST TO FLUSH, HE FOUND THAT THE DISTAL END OF 10.5 CM BEGAN TO LEAK, SO HE APPLIED FOR A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255394 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WHEN THE DOCTOR TEST TO FLUSH, HE FOUND THAT THE DISTAL END OF THE TUBE BEGAN TO LEAK, SO HE APPLIED FOR A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255381 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR TEST TO FLUSH, HE FOUND THAT THE DISTAL END OF THE TUBE BEGAN TO LEAK, SO HE APPLIED FOR A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255312 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT THE TUBE BROKE WITHIN ONE DAY OF BEING INSTALLED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255289 ↗
• MalfunctionAug 18, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN PLACED BY THE PHYSICIAN, THE GUIDE WIRE PENETRATES THE TUBE AND CANNOT BE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255197 ↗
• MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IT WAS FOUND THAT THERE WAS LEAK AT MARKED OF 21 CM FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196059 ↗
• MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAK AT MARKED OF 20 CM FROM THE CATHETER. PATIENT STATUS/ INTERVENTION: CHANGE NEW WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196024 ↗
• MalfunctionMay 21, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE CENTRAL VENOUS CATHETER PRESENTED WRINKLE AND PERFORATION UPON REMOVAL OF THE GUIDEWIRE, AFTER INSERTION, WITH APPLICATION OF ALL THE MANUFACTURER'S RECOMMENDATIONS AND INSERTION TECHNIQUE; TWO OCCURRENCES IN THE SAME PATIENT, IN JUGULAR VEIN PUNCTURE. THE NOTIFIER INFORMS, IN THE INVESTIGATION, THAT THEY INFUSED THE SOLUTION BEFORE, AND EVERYTHING WAS FINE, THEY PULLED THE GUIDEWIRE BEFORE CUTTING THE CATHETER TO THE INDICATED SIZE, BUT AT THE END OF INSERTION, AT THE TIME OF REMOVAL OF THE GUIDEWIRE, THE INCIDENT OCCURRED, REPEATING IT. SIMILARLY WHEN INSERTING THE SECOND CATHETER. THIS REPORT ADDRESSES THE FIRST DEVICE. NOTE: INTERVIEW WITH THE INITIAL NOTIFIER TO ASSESS THIS OCCURRENCE, THE SAME PROFESSIONAL WHO INSERTED THE CATHETERS: TWO CASES IN THE SAME PATIENT, FOLLOWING EACH OTHER; GAVE UP TRYING AGAIN AND PUNCTURED A PERIPHERAL VEIN WITH A SHORT CATHETER. SENT TO CONSULT THE NEONATAL ICU TEAM TO EVALUATE PERFORMANCE, WHERE THEY CORROBORATE THE INFORMATION ON THE POOR PERFORMANCE OF THIS CATHETER, WITH A NEGATIVE OPINION IN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465963 ↗
• MalfunctionMay 21, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE CENTRAL VENOUS CATHETER PRESENTED WRINKLE AND PERFORATION UPON REMOVAL OF THE GUIDEWIRE, AFTER INSERTION, WITH APPLICATION OF ALL THE MANUFACTURER'S RECOMMENDATIONS AND INSERTION TECHNIQUE; TWO OCCURRENCES IN THE SAME PATIENT, IN JUGULAR VEIN PUNCTURE. THE NOTIFIER INFORMS, IN THE INVESTIGATION, THAT THEY INFUSED THE SOLUTION BEFORE, AND EVERYTHING WAS FINE, THEY PULLED THE GUIDEWIRE BEFORE CUTTING THE CATHETER TO THE INDICATED SIZE, BUT AT THE END OF INSERTION, AT THE TIME OF REMOVAL OF THE GUIDEWIRE, THE INCIDENT OCCURRED, REPEATING IT. SIMILARLY WHEN INSERTING THE SECOND CATHETER. THIS REPORT ADDRESSES THE SECOND DEVICE. NOTE: INTERVIEW WITH THE INITIAL NOTIFIER TO ASSESS THIS OCCURRENCE, THE SAME PROFESSIONAL WHO INSERTED THE CATHETERS: TWO CASES IN THE SAME PATIENT, FOLLOWING EACH OTHER; GAVE UP TRYING AGAIN AND PUNCTURED A PERIPHERAL VEIN WITH A SHORT CATHETER. SENT TO CONSULT THE NEONATAL ICU TEAM TO EVALUATE PERFORMANCE, WHERE THEY CORROBORATE THE INFORMATION ON THE POOR PERFORMANCE OF THIS CATHETER, WITH A NEGATIVE OPINION IN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464996 ↗
• MalfunctionMay 20, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED A TECHNICAL COMPLAINT OF A PER-Q-CATH. ON (B)(6) 2022, 2FR CATHETER WAS INSERTED IN THE RIGHT EXTERNAL JUGULAR, AFTER THE PASSAGE, THERE WAS A BREAK IN THE INSERTION CLOSE TO THE CANNON (MICRO HOLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462014 ↗
• MalfunctionMay 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED 2FR CATHETER SHOWED A MICRO HOLE, OBSERVED BEFORE PERFORMING THE INSERTION, DURING SALINIZATION OF THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461863 ↗