Groshong Catheter 7755305Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741037757), received between Nov 23, 2015 and Mar 13, 2024 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "CATHETER INSERTED 10 DAYS AGO. LEAKAGE AT THE EXTERNAL PART OF THE PICC LINE (TOWARDS THE PUNCTURE SITE) AS IF THERE WERE A HOLE IN THE TUBING. THE PICC LINE HAD TO BE REMOVED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893258 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THERE WAS CATHETER BREAKAGE WITH A PICC ON (B)(6) 2015. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254891 ↗
• MalfunctionDec 23, 2020Material Puncture/Hole

  IT WAS REPORTED PICC GROSHONG 3FR CATHETER HAD 3 MICRO HOLES. ADDITIONAL INFORMATION REPORTED: WHEN WAS THE INCIDENT DETECTED? BEFORE, DURING OR AFTER USE ON THE PATIENT? DURING THE PROCEDURE ON PATIENT. WAS THERE BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. WHAT MEDICATION WAS BEING ADMINISTERED? NONE. WAS THERE ANY HARM TO THE PATIENT / HEALTHCARE PROFESSIONAL? (DETAIL) NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11068761 ↗
• MalfunctionFeb 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CATHETER WITH A TINY HOLE IN THE DISTAL TIP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768721 ↗
• MalfunctionAug 29, 2019Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT USED A PICC DEVICE (BARD GROSHONG 3FR). IT WAS NOTICED THAT THE DRESSING WAS WET, WHEN OPENING IT WAS IDENTIFIED THAT THE SILICONE CATHETER WAS SEPARATED FROM THE CONNECTOR. IT WAS DECIDED TO PERFORM THE REPAIR BY CHANGING THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946208 ↗
• MalfunctionAug 29, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT USED A PICC DEVICE (BARD - GROSHONG 3FR). IT WAS STATED THAT THE CONNECTOR WAS EXCHANGED AND AFTER THE EXCHANGE THERE WAS GREAT RESISTANCE SUGGESTING OBSTRUCTION, UNSUCCESSFUL NEGATIVE PRESSURE WAS ATTEMPTED AND THE CATHETER WAS REMOVED. UPON EXAMINING THE FULL LENGTH NO CLOTS WERE SEEN, BUT IT IS CLEAR THAT THE CONNECTOR IT WAS NOT PATENT. PERIPHERAL VENIPUNCTURE WAS REQUIRED TO COMPLETE THE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946199 ↗
• InjuryApr 24, 2018Disconnection; Migration or Expulsion of Device

  IT WAS REPORTED THE REPAIR ON THE CATHETER DISCONNECTED AND MIGRATED. IT REQUIRED HEMODYNAMIC SERVICE FOR REMOVAL OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 7456435 ↗
• InjuryMar 9, 2018Hole In Material

  IT WAS REPORTED THAT PATIENT USING PICC SHOWED PAIN AND AN INCREASE OF THE BRACHIAL PERIMETER. IT WAS STATED THERE WAS AN EDEMA IN THE UPPER LEFT LIMB. PICC USE WAS SUSPENDED, THE CASE WAS ASSESSED AND MEASURED, AND REASSESSED THE NEXT DAY IT SHOWS FIBROUS CORD. IT WAS ALSO FOUND THAT PICC HAD A HOLE AND A SOLUTION EXTRAVASATION.

  Patient problems: Edema; Extravasation; Pain

  MAUDE report 7329289 ↗
• InjuryMar 9, 2018Hole In Material

  IT WAS REPORTED THAT PATIENT USING PICC IN THE UPPER LEFT LIMB SHOWED PAIN AND AN INCREASE OF THE BRACHIAL PERIMETER, EDEMA IN THE UPPER LEFT LIMB. AFTER THAT THE USE OF THE PICC WAS SUSPENDED, THE CASE WAS ASSESSED AND MEASURED AND REASSESSED THE NEXT DAY IT SHOWS FIBROUS CORD. IT WAS ALSO FOUND THAT PICC HAS A HOLE AND A SOLUTION EXTRAVASATION. ON (B)(6) 3018 - IT WAS REPORTED THAT THE "FIBROUS CORD" IS A CONSEQUENCE OF A SUPERFICIAL THROMBOSIS. IT WAS STATED THAT "THE THROMBOTIC PROCESS THAT PROGRESSED TO FIBROSIS, WHICH DETERMINES THE PERMANENCE OF THE HARDENED VENOUS CORD.¿

  Patient problems: Edema; Extravasation; Fibrosis; Pain; Thrombosis

  MAUDE report 7329074 ↗
• MalfunctionJun 21, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO PLACING THE DEVICE THE CATHETER WAS FLUSHED AND NOTED A LEAK IN THE "MICRO HOLES". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6656477 ↗
• MalfunctionJun 14, 2017Hole In Material

  IT WAS REPORTED THAT MICRO HOLES WERE NOTED IN THE CATHETER AFTER INFUSION OF SODIUM CHLORIDE 0.9% BEFORE INSERTION IN THE PATIENT. DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6642375 ↗
• MalfunctionMay 4, 2017Hole In Material

  IT WAS REPORTED THAT THE PICC HAD A HOLE PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6544187 ↗
• MalfunctionFeb 17, 2017Hole In Material

  IT WAS REPORTED THAT A PERFORATION ON THE CATHETER WAS NOTED BEFORE STARTING THE PROCEDURE. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6340870 ↗
• MalfunctionAug 26, 2016Leak/Splash

  IT WAS REPORTED THAT THE CATHETER PRESENTED A LARGE LEAKAGE NEXT TO THE VALVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5906520 ↗
• MalfunctionJun 22, 2016Detachment Of Device Component; Connection Problem

  IT WAS REPORTED THAT A PICC LINE WAS INSERTED INTO A (B)(6) OLD PATIENT ON THURSDAY (B)(6) 2016 AS NORMAL AND DRESSED AS INTENDED. DURING THE 24 HOUR DRESSING CHANGE, IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE CATHETER HAD SEPARATED FROM THE CONNECTOR. PATIENT HAD A 4FR PICC INSERTED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5742287 ↗
• MalfunctionMar 24, 2016Cut In Material

  IT WAS REPORTED THAT THE CATHETER WAS PLACED ON (B)(6) 2016. IN THE MORNING TWO DAYS AFTER THE PLACEMENT, THE CATHETER WAS REPORTEDLY FOUND CUT INTO TWO PARTS. THE DEVICE WAS IMMEDIATELY REMOVED AND REPLACED IN THE OPERATIVE ROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5524741 ↗
• MalfunctionNov 23, 2015Break

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY BROKE AFTER THE CONNECTION HUB. NO PATIENT INJURY WAS REPORTED. (B)(6) 2015: ADDITIONAL INFORMATION RECEIVED: CATHETER WAS REPORTEDLY PLACED WITH A CHILD AND REMOVED WHEN ALLEGED BREAK IN CATHETER WAS OBSERVED, NO REPAIR KIT WAS SAID TO HAVE BEEN USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5243767 ↗