Per-Q-Cath Plus Catheter 4133105Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00801741074844), received between Dec 3, 2015 and Sep 20, 2023 — classified as 7 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (70 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 140 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Break; Break

  IT WAS REPORTED THE CATHETER RUPTURED WHEN INSERTED INTO THE PATIENT AND WAS COMPLETELY REMOVED WITH THE AID OF FORCEPS, WITHOUT CAUSING HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17785346 ↗
• MalfunctionAug 22, 2023Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A PICC CATHETER WAS PLACED AND DURING THE GUIDEWIRE REMOVAL IT UNRAVELED DURING TRACTION. IT WAS NEEDED TO RESTART THE PROCEDURE WITH A NEW CATHETER AND NEW INSERTION MATERIALS. ADDITIONAL INFORMATION RECEIVED 10 AUGUST 2023: THE PROCEDURE LASTED FOR ANOTHER 30 MINUTES, BEYOND THE SCHEDULED TIME. THE PATIENT COMPLAINED OF PAIN WHILE THE GUIDEWIRE WAS BEING REMOVED, IMAGING TESTS WERE PERFORMED, AND THE CURRENT PATIENT IS CLINICALLY STABLE, WITH IMPROVEMENT IN BREATHING PATTERNS. THERE WAS NO NEED TO ADMINISTER PAIN MEDICATION, AS THE PAIN RESOLVED AFTER REMOVAL OF THE GUIDE WIRE. A CHEST X-RAY WAS PERFORMED AFTER THE PROCEDURE TO ANALYZE WHETHER THERE WAS ANY DAMAGE CAUSED BY THE EVENT. THE PATIENT WOULD EXCHANGE THE CENTRAL VENOUS CATHETER FOR THE PICC DUE TO THE INDICATION TIME FOR PERMANENCE OF THE CENTRAL VENOUS CATHETER THAT HAD EXPIRED. THE PICC WOULD BE USED FOR THE INFUSION OF VENOUS SOLUTIONS NECESSARY FOR THE MAINTENANCE OF HIS LIFE. THERE IS NO OTHER RELEVANT HISTORY OR CONCOMITANT THERAPY.

  Patient problems: Pain

  MAUDE report 17597546 ↗
• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE MATERIAL PRESENTED AN ISSUE DURING ITS PLACEMENT. ACCORDING TO THE REPORTER, TO INSERT THE CATHETER INTO PATIENT IT WAS PERFORMED THE MANDREL REMOVAL AND TESTED WITH SALINE SOLUTION, WHEN THE SOLUTION WAS INFUSED A LEAKAGE WAS NOTED IN THE CATHETER. WHEN THE DEVICE WAS INSPECTED, A CRACK WAS OBSERVED. IT WAS NEEDED ANOTHER CATHETER TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773073 ↗
• MalfunctionJan 24, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "REQUESTED A PICC PLACEMENT IN PEDIATRIC ICU PATIENT. HOWEVER, WHEN PASSING THE PICC AND REMOVING THE GUIDEWIRE, IT DIDN'T COME OUT. 3 MORE PUNCTURE ATTEMPTS WERE TRIED AGAIN, AND THE ISSUE HAPPENED AGAIN. A NEW CATHETER WAS USED. " ON 11/23/2022: ADDITIONAL INFORMATION: IT WAS REPORTED, THERE WAS AN EXPOSURE IN A PROCEDURE THAT WAS NOT SUCCESSFUL DUE TO THE MATERIAL USED. DISSATISFACTION OF THE DOCTOR AND FAMILY MEMBERS AND FRUSTRATION FOR THE PROCEDURE DID NOT WORK. ON 11/28/2022: ADDITIONAL INFORMATION: IT WAS REPORTED, THE PATIENT¿S HOSPITAL STAY WAS NOT PROLONGED DUE TO THE UNSUCCESSFUL PICC PLACEMENT, BUT IT COULD HAVE OPTIMIZED THE TIME IF THE FIRST PASS WAS SUCCESSFUL. ON 1/6/2023 : FOUND DURING EVALUATION, THE RETURNED STYLET EXHIBITED MULTIPLE KINKS AND BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237482 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING THE JEJUNOSTOMY PROCEDURE, ACCORDING TO THE SURGEON'S REPORT, WHEN INSERTING THE PICC CATHETER, 3 MICROHOLES WERE OBSERVED AT THE PROXIMAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385058 ↗
• MalfunctionJun 16, 2022Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE GUIDEWIRE/STYLET FELL APART WHEN REMOVED. (B)(6) 2022: ADD INFO RECEIVED: WAS THERE ANY HARM TO THE PATIENT/HEALTH WORKER? THERE WAS NO HARM TO THE PROFESSIONAL OR THE PATIENT. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC.)?. IT WAS NOT NECESSARY HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? IF YES, WERE POST-EXPOSURE PROPHYLACTIC ACTIONS TAKEN? NO WHAT TREATMENT WAS THE PATIENT UNDERGOING? THE CATHETER WAS PASSED DUE TO THE NEED FOR PROLONGED ANTIBIOTIC THERAPY, BUT THE CATHETER WAS NOT USED (PROBLEM DURING PASSING). WHAT WAS THE ACCESS LOCATION? CUBITAL FOSSA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717994 ↗
• MalfunctionJun 16, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PICC CATHETER INSERTION PROCEDURE, THE CATHETER BROKE IN HALF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717782 ↗
• InjuryMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CRACK WITH OVERFLOW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317196 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER WAS INSERTED IN A PATIENT AND HAD A MICROHOLE WHEN IT RETURNED FOR MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317107 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETER ALREADY INSERTED IN A PATIENT, HAS A MICROHOLE WHEN IT RETURNS FOR MAINTENANCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316944 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO THE APPLICATION OF CHEMOTHERAPY, A FLUSH WAS PERFORMED (SALINIZATION) AND A MICROHOLE WAS OBSERVED IN THE CATHETER, WITH SALINE SOLUTION LEAKING INTO THE DRESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316708 ↗
• MalfunctionDec 30, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOLE AT THE BEGINNING OF TWO CATHETERS WERE NOTED PRIOR TO USE. THIS REPORT ADDRESSES THE SECOND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120602 ↗
• MalfunctionDec 30, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOLE AT THE BEGINNING OF TWO CATHETERS WERE NOTED PRIOR TO USE. THIS REPORT ADDRESSES THE FIRST CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120582 ↗
• MalfunctionDec 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN PERFORMING THE CATHETER WASHING TEST PRIOR TO ACCESS PUNCTURE, THE TEAM OBSERVED THE PRESENCE OF LEAKAGE AND EVIDENCED THAT THE CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025264 ↗
• MalfunctionDec 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC 3 FR CATHETER, FOUND HOLE AND SOLUTION LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924738 ↗
• MalfunctionNov 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER HAS A PROXIMAL MICROHOLE. PROCEDURE IN WHICH THE PROBLEM OCCURRED: PASSAGE OF THE CATHETER. IDENTIFIED BEFORE USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12903633 ↗
• MalfunctionOct 5, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS IN USE FOR 4 DAYS UNTIL A CRACK WAS NOTED NEAR BY SUTURE WING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580490 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS PERFORMED A PUNCTURE IN LEFT EXTERNAL JUGULAR VEIN FOR A PICC PASSAGE IN A PEDIATRIC PATIENT, FOLLOWING ALL TECHNICAL INSTRUCTIONS FOR THE PROCEDURE, INCLUDING TESTING THE DEVICE WITH SALINE SOLUTION PRIOR IMPLANTING THE PICC. AFTER INSERTING THE PICC, A NEW TEST WAS DONE WITH SALINE SOLUTION, AND IT WAS OBSERVED A LEAKAGE OF THE SALINE FROM THE HUB. THE PICC WAS REMOVED AND IT WAS PERFORMED A NEW PUNCTURE IN RIGHT EXTERNAL JUGULAR VEIN TO ACCESS IT WITH A NEW PICC FROM SAME BATCH. SO AS BEFORE, THE DEVICE WAS TESTED WITH SALINE SOLUTION PRIOR THE USE, BUT AFTER INSERTION IT WAS OBSERVED A LEAKAGE OF THE SOLUTION DURING A TEST DONE AFTER THE INSERTION INTO PATIENT. BOTH TIMES IT WAS USED A STATLOCK FOR FIXATION. IN A SINGLE PROCEDURE/EVENT, TWO DEVICES PRESENTED A FRACTURE OF THE CATHETER NEARBY THE HUB, IMMEDIATELY AFTER THE INSERTION INTO PATIENT, WHEN TESTED. THE PATIENT IS UNDER A TREATMENT FOR AN INFECTIOUS DISEASE AND GOES ON WITH HOSPITALIZATION WITHOUT IMPACT DUE TO THE ISSUE. BOTH CATHETERS HAVE BEEN DISCARDED AS A SAFETY MEASURE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253649 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS PERFORMED A PUNCTURE IN LEFT EXTERNAL JUGULAR VEIN FOR A PICC PASSAGE IN A PEDIATRIC PATIENT, FOLLOWING ALL TECHNICAL INSTRUCTIONS FOR THE PROCEDURE, INCLUDING TESTING THE DEVICE WITH SALINE SOLUTION PRIOR IMPLANTING THE PICC. AFTER INSERTING THE PICC, A NEW TEST WAS DONE WITH SALINE SOLUTION, AND IT WAS OBSERVED A LEAKAGE OF THE SALINE FROM THE HUB. THE PICC WAS REMOVED AND IT WAS PERFORMED A NEW PUNCTURE IN RIGHT EXTERNAL JUGULAR VEIN TO ACCESS IT WITH A NEW PICC FROM SAME BATCH. SO AS BEFORE, THE DEVICE WAS TESTED WITH SALINE SOLUTION PRIOR THE USE, BUT AFTER INSERTION IT WAS OBSERVED A LEAKAGE OF THE SOLUTION DURING A TEST DONE AFTER THE INSERTION INTO PATIENT. BOTH TIMES IT WAS USED A STATLOCK FOR FIXATION. IN A SINGLE PROCEDURE/EVENT, TWO DEVICES PRESENTED A FRACTURE OF THE CATHETER NEARBY THE HUB, IMMEDIATELY AFTER THE INSERTION INTO PATIENT, WHEN TESTED. THE PATIENT IS UNDER A TREATMENT FOR AN INFECTIOUS DISEASE AND GOES ON WITH HOSPITALIZATION WITHOUT IMPACT DUE TO THE ISSUE. BOTH CATHETERS HAVE BEEN DISCARDED AS A SAFETY MEASURE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253648 ↗
• MalfunctionJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS A LEAKAGE IN CATHETER/HUB CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218035 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED, AT WHICH TIME THE DEVICE WAS RUPTURED, REQUIRING SURGICAL INTERVENTION FOR TOTAL REMOVAL. ADDITIONAL INFORMATION RECEIVED: CUSTOMER SENT TO US THE ADDITIONAL INFORMATION. PLEASE SEE BELLOW. WHAT IS THE DATE OF OCCURRENCE OF THE EVENT? (B)(6) 2021. HOW LONG HAS THE PATIENT USED THE CATHETER? (B)(6) 2021. WAS THERE A MIGRATION OF THE CATHETER FRAGMENT IN THE PATIENT? YES. WAS THERE ANY HARM TO THE PATIENT BEYOND THE NEED FOR SURGICAL INTERVENTION? (DETAIL) AFTER THE SURGICAL INTERVENTION, HE REMAINED INTUBATED AND WAS REFERRED TO THE PEDIATRIC ICU. WAS THERE A NEED FOR ANY ADDITIONAL MEDICAL INTERVENTION? (DETAIL) IN THE PEDIATRIC ICU, THE PATIENT WAS EXTUBATED WITHIN THE FIRST FEW HOURS AND REMAINED UNDER OBSERVATION. RELEASED TO THE INPATIENT POST ON THE SAME DAY. WAS THERE AN EXTENSION OF THE PATIENT'S HOSPITAL STAY? (DETAIL) YES, 48 HOURS. WAS THE PRODUCT BEING USED IN THE MANAGEMENT OF COVID-19? NO.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211022 ↗
• MalfunctionJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS WITH SHORT TIME OF USE, SHOWING CRACKS AND SO LEAKAGE. MOST OF THE CRACKS HAVE BEEN HAPPENING AT THE HUB. CHILDREN WILL NEED A NEW CATHETER PROGRAMMING, BEING EXPOSED AGAIN TO SEDATION TO PERFORM THE PROCEDURE. CATHETER INSERTION DATE: (B)(6) 2021, REMOVED ON (B)(6) 2021 DUE TO LEAKAGE AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183522 ↗
• MalfunctionJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS WITH SHORT TIME OF USE, SHOWING CRACKS AND SO LEAKAGE. MOST OF THE CRACKS HAVE BEEN HAPPENING AT THE HUB. CHILDREN WILL NEED A NEW CATHETER PROGRAMMING, BEING EXPOSED AGAIN TO SEDATION TO PERFORM THE PROCEDURE. CATHETER INSERTION DATE (B)(6) 2021, REMOVED IN THE PATIENT'S CITY OF ORIGIN DUE TO EXTRAVASATION IN A HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183451 ↗
• MalfunctionJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS WITH SHORT TIME OF USE, SHOWING CRACKS AND SO LEKAGE. MOST OF THE CRACKS HAVE BEEN HAPPENING AT THE HUB. CHILDREN WILL NEED A NEW CATHETER PROGRAMMING, BEING EXPOSED AGAIN TO SEDATION TO PERFORM THE PROCEDURE. CATHETER INSERTION DATE: (B)(6) 2021, REMOVED (B)(6) 2021 DUE TO LEAKAGE IN HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183436 ↗
• MalfunctionJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETERS WITH SHORT TIME OF USE, SHOWING CRACKS AND SO LEAKAGE. MOST OF THE CRACKS HAVE BEEN HAPPENING AT THE HUB. CHILDREN WILL NEED A NEW CATHETER PROGRAMMING, BEING EXPOSED AGAIN TO SEDATION TO PERFORM THE PROCEDURE. CATHETER INSERTION DATE (B)(6) 2021 AND REMOVAL ON (B)(6) 2021 DUE TO RUPTURE IN HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183409 ↗