Groshong Catheter 7715305Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741035289), received between Sep 17, 2020 and Aug 11, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA HEALTH (B)(4) MEDICAL DEVICES ONLINE DATABASE: "E0506 - HEMORRHAGE/BLEEDINGF23 - UNEXPECTED MEDICAL INTERVENTIONF05 - DELAY TO TREATMENT/THERAPYA0404 - CRACKA050401 - FLUID LEAKA26." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12308274 ↗
• MalfunctionMay 25, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PROXIMAL END OF THE GUIDE WIRE WAS FOUND DETACHED BEFORE THE PRODUCT WAS USED. THE OPERATOR OPENED A NEW KIT FOR PUNCTURE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876561 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT NOTICED BLOOD LEAKING FROM THE PICC LINE. THE PICC LINE WAS CLAMPED AND REPLACED. IT WAS STATED, WHILE TRYING TO FLUSH THE LINE WITH NORMAL SALINE, A CRACK IN THE PICC LINE NEAR THE HUB WAS NOTED. THE PICC HAD BEEN INSERTED ON (B)(6) 2020.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11532267 ↗
• MalfunctionOct 14, 2020Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE HEALTH CANADA WEBSITE THAT A FACILITY REPORTED A CRACK/FLUID LEAK AND HEMORRHAGE/BLEEDING . IT WAS REPORTED THERE WAS UNEXPECTED MEDICAL INTERVENTION AND DELAY TO TREATMENT/THERAPY. NO FURTHER INFORMATION. CAUSE NOT ESTABLISHED.

  Patient problems: Blood Loss

  MAUDE report 10679978 ↗
• MalfunctionSep 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT REP RECEIVED A PRODUCT COMPLAINT FROM HOSPITAL FOR OUR GROSHONG 3 FR BASIC KIT (7715305). AFTER CATHETER INSERTION WITHIN 24 HR THEY FOUND A LEAKAGE IN THE CATHETER, SO THEY TOLD US THEY WILL GOING TO REMOVE THE CATHETER. 10-SEP-2020 INFORMATION RECEIVED FROM CUSTOMER: THE LEAKAGE WAS EXTERNAL SO WHENEVER THEY INFUSE ANY MEDICATION OR SALINE THAT WAS LEAKING, NO BLOOD LEAKAGE. PICC WAS PLACED SO BLOOD EXPOSURE WAS THERE. SOME DELAY HAPPENED IN MEDICATION DELIVERY BUT THEY CALLED THE IR WHO PLACED THE PICC AND HE MANAGED TO REPAIR THE LINE WITH THE SECOND REPAIR KIT INSIDE THE KIT WHICH THEY KEPT SAFELY, AFTER THAT THEY ARE USING THE SAME LINE FOR ALL MEDICATION. AS PER THE DETAILS PROVIDED BY THE DR THEIR WAS SOME DAMAGE IN THE CATHETER EXTERNALLY AND THEY MANAGED TO REPAIR THAT. STAFF MANAGED TO REPAIR AND USE THE SAME LINE. IT WAS STATED THE NURSE WHO PLACED THIS LINE IS EXPERIENCED AND ALWAYS USES A 10CC SYRINGE FOR MEDICATION INFUSION AND FLUSHING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547641 ↗