Per-Q-Cath Plus Catheter 4132005Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741074820), received between Nov 9, 2015 and Jun 7, 2023 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER TECHNICAL AREA, "PICC RUPTURED SPONTANEOUSLY AFTER 8 DAYS OF USE IN THE NB, WHILE INFUSING INTRAVENOUS HYDRATION. IT RUPTURED ON THE OUTSIDE, WAS REMOVED IMMEDIATELY, NEONATOLOGIST INFORMED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083603 ↗
• InjuryOct 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC'S HUB RUPTURED, CAUSING PHLEBITIS AT PUNCTURE SITE.

  Patient problems: Vasculitis

  MAUDE report 15587614 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED "PICC WAS FOUND BROKEN ON THE PATIENT'S BED, I PERFORM THE EVALUATION AT THE MOMENT AND VISUALIZE A BUTTERFLY OF THE PICC ON THE BED WITH A BANDAGE WELL ADHERED TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122828 ↗
• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED, "CATHETER PRESENTED A RUPTURE AFTER FLUSHING." IT WAS STATED THAT THE CATHETER WAS RESISTING AND BROKE IN THE CANNON DURING FLUSHING. ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTH WORKER? (DETAIL). PASSAGE OF A NEW CATHETER - NO MAJOR DAMAGE. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? NO. HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? NO. WHAT MEDICATION WAS BEING ADMINISTERED? FLUSHING WITH SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599965 ↗
• MalfunctionSep 24, 2021Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED WHITE CANNULA POSSIBLY CAUSES A "BEND" IN THIS CATHETER, CAUSING RESISTANCE, WHICH IMPAIRS THE FLOW OF THE INFUSION. IT WAS STARTED IT MAY BE CAUSING OBSTRUCTION. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: DUE TO LOSS OF THE CATHETER DUE TO OBSTRUCTION, A NEW PROCEDURE HAD TO BE PERFORMED, BEING ANOTHER INVASIVE PROCESS FOR THE PATIENT, WITH RISK OF INFECTION. AFTER OBSTRUCTION OF THE CATHETER IN A PATIENT WITH DIFFICULT VENOUS ACCESS, A PROCEDURE CALLED PHLEBOTOMY HAD TO BE PERFORMED. EVERY PICC PASS INVOLVES X-RAY AND THE USE OF CONTRAST TO VISUALIZE ITS LOCATION. PARENTERAL NUTRITION, VASOACTIVE DRUGS, ANTIBIOTICS, SEDATION, ETC. WERE BEING ADMINISTERED TO THIS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527571 ↗
• MalfunctionSep 24, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED CATHETER TWISTS DURING PASSAGE, AND HAS A VERY HIGH CLOGGING RATE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527500 ↗
• MalfunctionSep 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETER HAS A CONNECTOR THAT OVERFLOWS WHAT IS BEING ADMINISTERED (DRUGS AND PARENTERAL NUTRITION). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527466 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THE CATHETER BODY WAS DETACHED FROM THE EXTERNAL PART OF THE CATHETER, NO CHANGE DRESSING WAS DONE, NO SHARP OBJECTS USED CLOSE TO THE AREA. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525901 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THE PICC LINE WAS INSERTED IN THE RIGHT HAND AND PRESENT FOR 29 DAYS. IT WAS DISCOVERED THAT THE LINE WAS BROKEN APART FROM THE "HUB" (LINE WAS SAVED AT THE BEDSIDE) THE LINE WAS IMMEDIATELY REMOVED AND A PERIPHERAL IV INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215637 ↗
• MalfunctionJul 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER RUPTURED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144647 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS ARE RUPTURING. NO OTHER INFORMATION PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139919 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS ARE RUPTURING. NO OTHER INFORMATION PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139916 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS ARE RUPTURING. NO OTHER INFORMATION PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139915 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS ARE RUPTURING. NO OTHER INFORMATION PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139904 ↗
• MalfunctionApr 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN HEPARINIZED, IT STARTED TO PRESENT A LEAK. ON 4/23/2020 - ADDITIONAL INFORMATION RECEIVED: THERE WAS NO HARM TO THE PATIENT/HEALTH PROFESSIONAL BECAUSE THEY IDENTIFIED THE ISSUE PRIOR INSERTION. THERE WAS NO MEDICAL/SURGICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 10011532 ↗
• MalfunctionMar 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, WHEN PERFORMING THE PROCEDURE, AFTER THE FIRST PUNCTURE, THE INTRODUCER RUPTURED AND DEFORMED MAKING IT IMPOSSIBLE TO USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789410 ↗
• MalfunctionMar 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020 WHEN PERFORMING THE PROCEDURE, AFTER THE FIRST PUNCTURE, THE INTRODUCER RUPTURED AND DEFORMED MAKING IT IMPOSSIBLE TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789407 ↗
• MalfunctionAug 29, 2019Moisture or Humidity Problem

  IT WAS REPORTED THAT ON EXAMINATION OF THE NEWBORN, THE BANDAGE WAS OBSERVED MOIST, THE PERMEABILITY WAS CHECKED AND SHOWED DRAINED BY THE WALL. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946548 ↗
• MalfunctionSep 27, 2018Material Rupture

  IT WAS REPORTED RUPTURE OF THE CATHETER WITH NO APPARENT CAUSE. IT WAS STATED THE STANDARD PROTOCOL OF HANDLING WAS FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915743 ↗
• MalfunctionApr 11, 2018Break

  IT WAS REPORTED THAT "THE CATHETERS ARE EASILY BROKEN WHEN INSTALLED IN THE NEONATES, SO IT IS NECESSARY TO CHANGE THE CATHETERS FREQUENTLY CAUSING MULTIFUNCTIONS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7422531 ↗
• MalfunctionApr 11, 2018Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS ARE OF VERY POOR QUALITY, AND THEIR DURABILITY IS OF 5 DAYS, SO IT IS NECESSARY TO CHANGE THE CATHETERS, WHICH RESULTS IN THE HANDLING OF THE PATIENT AND RISK OF INFECTIONS. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7422516 ↗
• InjuryApr 11, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED REACTION IN THE PATH OF THE CATHETER. IT WAS STATED THIS HAPPENED ON MULTIPLE PATIENTS BUT EXACT NUMBER IS UNKNOWN.

  Patient problems: Reaction

  MAUDE report 7422498 ↗
• MalfunctionDec 21, 2017Poor Quality Image; Material Opacification

  IT WAS REPORTED THAT THE CATHETER HAD LOW RADIOPACITY. THE X-RAY VIEW SHOWED THE CATHETER AT THE INSERTION SITE BUT THE FINAL LOCATION WAS NOT VISUALIZED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139936 ↗
• MalfunctionJun 29, 2017Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT CATHETER INTRODUCER PRESENTED RUPTURE AFTER THE FIRST ATTEMPT OF PUNCTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676557 ↗
• MalfunctionJun 27, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT PERFORMED PICC PASS AND AFTER X-RAY WITH REPETITIONS, IT WAS NOT POSSIBLE TO SEE THE LOCAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672336 ↗