Groshong 7711700Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741036736), received between Dec 4, 2015 and Sep 13, 2024 — classified as 1 death, 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE ITEM WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217857 ↗
• MalfunctionDec 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FILTHY AND WAS TOO DIRTY TO USE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333915 ↗
• DeathJun 8, 2023Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT FIVE MONTHS AND EIGHT DAYS POST THE CHRONIC CATHETER PLACEMENT, AN ALLEGED CRACK WAS OBSERVED ON THE CATHETER VALVE CONNECTOR CAUSING AIR EMBOLISM. IT WAS FURTHER REPORTED THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT WAS BEING TREATED FOR SEVERE PULMONARY ARTERIAL HYPERTENSION AND EPOPROSTENOL WAS BEING ADMINISTERED. PATIENT'S CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 17084562 ↗
• MalfunctionJun 20, 2022Fluid/Blood Leak; Suction Problem; Air/Gas in Device; Fluid/Blood Leak; Suction Problem; Air/Gas in Device

  IT WAS REPORTED THAT FOUR DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKING LIQUID FROM THE EXTERNAL PART OF THE CATHETER. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY HAD NO BLOOD RETURN AND AIR WAS ALLEGEDLY PRESENT IN THE TUBING OF THE DEVICE. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741844 ↗
• MalfunctionFeb 3, 2022Material Separation; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Material Separation; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  IT WAS IDENTIFIED DURING INVESTIGATION THAT THE MATERIAL OF THE DEVICE WAS ALLEGEDLY CUT AND HAD MATERIAL SEPARATION ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13439727 ↗
• MalfunctionOct 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT POST CATHETER IMPLANT, FOREIGN MATERIAL WAS ALLEGEDLY FOUND TO BE DEPOSITED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12709959 ↗
• MalfunctionAug 31, 2021Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD BLEED BACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391399 ↗
• MalfunctionApr 16, 2020Fracture; Material Frayed; Fracture; Material Frayed

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711700 CHRONIC CATHETER WAS ALLEGEDLY EXPERIENCED MATERIAL FRAYED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9970037 ↗
• MalfunctionApr 8, 2020Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711700 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT, THEREFORE, PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9941715 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711700. CHRONIC CATHETER ALLEGEDLY EXPERIENCE FRACTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602434 ↗
• MalfunctionApr 19, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENT INDICATED THAT MODEL 7711700 CHRONIC CATHETER ALLEGEDLY HAD A DEFECTIVE COMPONENT. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT¿S AGE, SEX, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532730 ↗
• MalfunctionApr 18, 2018Fluid/Blood Leak; Hole In Material; Material Rupture

  IT WAS REPORTED VIA MEDWATCH THAT THE PATIENT HAD A SINGLE LUMEN GROSHONG CATHETER VIA THE RIGHT INTERNAL JUGULAR VEIN. THE NURSE HAD DRAWN BLOOD FROM THE CATHETER WITHOUT ANY PROBLEMS AND WAS FLUSHING THE CATHETER WITH SALINE. THE CENTRAL LINE RUPTURED WITH SALINE SPURTING OUT OF SMALL HOLES IN THE CATHETER. THE CATHETER WAS REPAIRED BY THE INFUSION SPECIALIST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440743 ↗
• MalfunctionFeb 28, 2018Unintended Movement

  FACILITY REPORTED TO THE SALES REP THAT THE CUFF ON THE CATHETER WAS NOT SECURE AND WAS "MOVING". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304410 ↗
• MalfunctionNov 22, 2017Mechanics Altered

  IT WAS REPORTED BY THE FACILITY THAT THE 7 FR GROSHONG CATHETER MALFUNCTIONED. NO OTHER INFORMATION WAS PROVIDED, BUT HAS BEEN REQUESTED. ON (B)(6) 2017-PHOTO PROVIDED SHOWS STYLET WAS NOT REMOVED AND LUER LOCK INCORRECTLY ATTACHED TO CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054233 ↗
• InjuryNov 10, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING CARE AND MAINTENANCE PROCESS THE NURSE FOUND THE CATHETER WAS COMPLETELY DISPLACED, BUT THE DACRON PART WAS STILL INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7020819 ↗
• MalfunctionNov 1, 2017Device Slipped

  IT WAS NOTICED THAT THE CUFF WAS SLIPPING PROXIMALLY UP THE LINE. THE HOSPITAL STATED THIS HAD NOT BEEN SEEN BEFORE AND THE LINE WAS NOT BEING TUGGED THROUGH PARTICULARLY FIRMLY. IT WAS STATED THE PATIENT WAS A HEMOPHILIAC AND WAS "OOZY" SO THE HOSPITAL DIDN'T OPEN UP THE NECK POCKET AND PUSH THE CUFF DOWN INTO THE TUNNEL. IT WAS REPORTED THE DEVICE IS STILL IN AND THE PATIENT IS CURRENTLY FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6993662 ↗
• InjurySep 26, 2017Break; Detachment Of Device Component; Connection Problem

  IT WAS REPORTED THAT THE NURSE FIRST NOTED THE BLUE PRESSURE HUB WOULDN'T ATTACH PROPERLY TO THE GROSHONG PORT. THE GUIDE WIRE REMAINED IN THE CATHETER AND A BLUNT FLUSH CAP WAS ATTACHED TO THE GUIDEWIRE'S HUB. AFTER PLACEMENT THE PHYSICIAN INITIALLY STATED THAT THERE WASN'T A GUIDE WIRE IN PLACE AND THIS WAS CONFIRMED BY AN X-RAY WHERE NO GUIDEWIRE COULD BE SEEN. FURTHER EXAMINATION INDICATED THERE WAS IN FACT A WIRE LEFT INSIDE THE PATIENT. THEY BELIEVE IT WAS LEFT INSIDE THE PATIENT BECAUSE IT HAD BROKEN OFF OF THE ORIGINAL CAP. AFTER THE SURGEON REMOVED THE WIRE IT WAS COMPARED TO A FRESH GROSHONG CATHETER KIT, THEY NOTED NO APPEARANCE OF DAMAGE TO THE WIRE, BOTH WIRES MEASURED 19.5 INCHES AND THEY SURMISED THAT NOTHING REMAINED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 6895304 ↗
• MalfunctionOct 25, 2016Device Dislodged or Dislocated

  ON (B)(6) 2016 - FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT DURING THE TUNNELING PROCEDURE AND ADJUSTMENT OF THE CATHETER PLACEMENT, THE DACRON CUFF CAME DISLODGED FROM THE CATHETER. THIS NECESSITATED THE REMOVAL OF THE ITEM AND REPLACEMENT WITH THE SECOND CATHETER. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6056074 ↗
• InjuryFeb 24, 2016Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR THE REMOVAL OF CATHETER WHICH WAS BROKEN AND HAD DISINTEGRATED. REMOVAL WAS BY PUNCTURE UNDER ECHO CONTROL VIA THE RIGHT FEMORAL AND THE CAPTURE OF THE CATHETER TIP WAS AT THE RIGHT AURICLE. THE REMOVAL WAS REPORTEDLY IMPOSSIBLE DUE TO A TOTAL CALCIFICATION OF THE CATHETER. THE REMOVAL ATTEMPT FAILED AND THE DOCTOR DECIDED TO STOP THE PROCEDURE BECAUSE THERE WAS NO RISK OF MIGRATION. THE PATIENT RETURNED TO HIS HOME AND REMAINS UNDER MEDICAL SUPERVISION. THE CATHETER WAS PLACED IN THE PATIENT 14 YEARS AGO.

  Patient problems: Calcium Deposits/Calcification; Device Embedded In Tissue or Plaque

  MAUDE report 5457515 ↗
• InjuryFeb 5, 2016Break

  IT WAS REPORTED THAT AFTER USING THE CATHETER FOR PERFUSION (VELETRI DURING THREE WEEKS, IT BROKE. THE DEVICE WAS CHANGED. ON (B)(6) 2016 - IT WAS REPORTED THE CATHETER BROKE INTO TWO PIECES. THE PIECES WERE RECOVERED BY EXTRACTION. THE FACILITY STATES THEY DO NOT KNOW WHERE THE DAMAGE WAS BUT THE SAMPLE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 5413749 ↗
• InjuryJan 25, 2016Fluid/Blood Leak; Fracture; Application Program Problem: Medication Error; Fluid/Blood Leak; Fracture; Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE GROSHONG TUNNELLED LINE HAD A LEAK, THE LINE WAS REPAIRED. THE FACILITY REPORTS THE LINE WAS PLACED (B)(6) 2014 AND HAS HAD 5 REPAIRS SINCE INSERTION. THE REPORTED LEAK WAS BENEATH THE CONNECTOR CUFF AND OCCURRED DURING TPN INFUSION. PATIENT HAD A WET TOP AND SAW TPN LEAKING FROM BENEATH THE CUFF. NO LEAKAGE WAS OBSERVED DURING FLUSHING. THE LEAK OCCURRED ON (B)(6) 2015 AND WAS REPAIRED ON (B)(6) 2015. THE PATIENT EXPERIENCED MILD DEHYDRATION BECAUSE 1L OF TPN WAS WASTED. THE PATIENT WAS ADMITTED 48 HOURS AFTER THE FRACTURE WITH A HIGH TEMPERATURE AND POSSIBLE LINE INFECTION. THE PATIENT WAS SEEN BY NUTRITION NURSE THE FOLLOWING AFTERNOON FOR AN URGENT REPAIR. THE FACILITY DIAGNOSED AN INFECTION ON (B)(6) 2015. CULTURES GREW COAGULASE NEGATIVE STAPH. PATIENT ON INTRAVENOUS ANTIBIOTICS FOR 1 TO 2 WEEKS IN ORDER TO SALVAGE THE LINE. 1/20/2016 - LAB RESULTS WERE NOTED TO BE POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS, WHICH WAS SENSITIVE TO TEICOPLANIN. CULTURES WERE DRAWN PERIPHERALLY. LAB NOTES FROM 8/12/2016 RECOMMEND TREATING THE PATIENT WITH TEICOPLANIN FOR 7 DAYS WITH REPEAT BLOOD CULTURES PERIPHERALLY AND CENTRALLY 48 AND 72 HOURS AFTER TREATMENT. NO

  Patient problems: Bacterial Infection; Dehydration; Pain; Sepsis; Unspecified Infection

  MAUDE report 5389800 ↗
• InjuryDec 4, 2015Migration or Expulsion of Device; Material Rupture; Detachment of Device or Device Component

  (B)(6) 2015 IT WAS REPORTED THAT A HEALTHCARE PROVIDER NOTED AN ALLEGED DISTAL RUPTURE OF THE CATHETER AND A MIGRATION OF THE ALLEGED BROKEN PORTION INTO THE RIGHT PULMONARY ARTERY. THE PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE THE DETACHED MATERIAL WAS REMOVED.

  Patient problems: Not Applicable

  MAUDE report 5269085 ↗