PowerGroshong Catheter 7818518Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741028533), received between Mar 11, 2016 and Apr 19, 2019 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2019Break

  IT WAS REPORTED THAT ON MARCH 10TH A CLIENT REPORTED THAT THEIR PICC HAD ALLEGEDLY "BROKEN". THEY STATED THAT IT JUST ALLEGEDLY HAPPENED, NO UNTOWARD ACTIONS HAPPENED ON THEIR PART (SCISSORS, ETC). IT WAS INSERTED AT LGH ON MARCH 4TH AND THE LOT # WAS RECX1506. PATIENT WAS SENT TO VGH ER WHERE THEY REMOVED IT (AND THREW IT AWAY SADLY) AND THE CLIENT HAD A NEW ONE INSERTED THE NEXT DAY. PATIENT OUTCOME/STATUS REPORTED AS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533460 ↗
• MalfunctionApr 11, 2019Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PICC HAS AN ALLEGED HOLE AT 40 CM. A NEW PICC WAS INSERTED MARCH 25.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504681 ↗
• MalfunctionApr 10, 2019Fracture

  IT WAS REPORTED THAT PICC INITIALLY INSERTED (B)(6) 2019 USING SECURECATH SECUREMENT DEVICE FRACTURED (B)(6), RE-INSERTED ON (B)(6). PICC REMOVED, REPLACED. PATIENT OUTCOME/STATUS IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500551 ↗
• InjuryApr 4, 2019Entrapment of Device; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT PATIENT ALLEGEDLY DEVELOPED EXTRAVASATION, IRRITANT TYPE, FOLLOWING THE FOURTH AND THE LAST CYCLE OF CHEMOTHERAPY, DUE TO EXTRAVASATION OF DOCETAXEL THROUGH AN ALLEGED LEAK OF THE PICC LINE; THE PICC WAS VERY GENTLY WITHDRAWN AND IMMEDIATELY FRACTURED AT THE KINKED CATHETER SITE. THE SHORT FRAGMENT SEPARATED FROM THE LONG PICC. THE PICC WAS IMMEDIATELY BURIED IN THE SUBCUTANEOUS TISSUES OF THE RIGHT ARM. ENTIRE PICC DEMONSTRATES INTEGRITY UP TO JUST BENEATH THE ACCESS SITE WHERE THE PICC IS KINKED IN THE SUBCUTANEOUS TISSUES. MOST LIKELY, THERE WAS A PINCH OFF WHICH RESULTED IN WEAKNESS OF THE CATHETER AND A SMALL TEAR IN THE PICC RESULTING IN EXTRAVASATION OF INFUSED MEDICATIONS CAUSING ARM EDEMA AND VENOUS THROMBOSIS. PATIENT WAS ADMITTED FOR FIVE DAYS WITH COMPLICATIONS RELATED TO THIS EVENT - RIGHT ARM DVT AND CELLULITIS/IRRITATIVE CONTACT DERMATITIS (RIGHT UPPER EXTREMITY) DUE TO EXTRAVASATION OF CHEMOTHERAPY (DOCETAXEL).

  Patient problems: Extravasation; Irritation; Thrombosis; Unspecified Infection

  MAUDE report 8482468 ↗
• InjuryNov 20, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT SAID IT WAS ALLEGEDLY LEAKING. IT WAS A 5F GROSHONG. THE NURSES CHECKED IT AND DECIDED TO CHANGE IT OUT FOR A NEW ONE. WHEN THE NURSE WENT TO PULL OUT THE OLD PICC THERE WAS ALLEGEDLY NONE OF THE USUAL RESISTANCE AND STRETCH, IT APPARENTLY JUST ¿SNAPPED¿ OFF. THE DOCTOR DID A CUT DOWN TO REMOVE THE REST OF THE PICC. THE PATIENT WAS ON IVIG THAT REQUIRES D5W FLUSHES POST INJECTION AND THEN SALINE AFTER OR CRYSTALS CAN FORM IN PICC. NO PATIENT INJURY REPORTED. THIS FILE IS FOR FIRST OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046289 ↗
• InjuryNov 20, 2017Break; Detachment Of Device Component; Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PATIENT SAID THEIR PICC WAS ALLEGEDLY LEAKING SO THE NURSE DECIDED TO CHANGE IT OUT FOR A NEW ONE. WHEN THE NURSE WENT TO PULL OUT THE OLD PICC THERE WAS ALLEGEDLY NONE OF THE USUAL RESISTANCE AND STRETCH, IT APPARENTLY JUST ¿SNAPPED¿ OFF. THE DOCTOR DID A CUT DOWN TO REMOVE THE REST OF THE PICC. THE PATIENT WAS ON IVIG THAT REQUIRES D5W FLUSHES POST INJECTION AND THEN SALINE AFTER OR CRYSTALS CAN FORM IN PICC. NO PATIENT INJURY REPORTED. THIS FILE IS FOR SECOND OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046287 ↗
• MalfunctionFeb 7, 2017Crack; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PICC WAS PLACED ON (B)(6) 2016, FOR CHEMOTHERAPY. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2017, TO DISCONNECT THE INFUSOR BOTTLE. IT WAS STATED THAT WHILE FLUSHING THERE WAS LEAKING AT THE SITE. THE PICC WAS REMOVED IN THE CLINIC BY THE HCN, IT IS ALLEGED THAT THERE IS A CRACK AT APPROXIMATELY 2CMS BELOW THE EXTERNAL MARKING. PATIENT HAS STATED THAT THEY HAVE NOT ADHERED TO THE ACTIVITY RESTRICTIONS AT ALL TIMES WHILE THE PICC WAS IN PLACE AND CONTINUED TO REMAIN ACTIVE WHILE RECEIVING TREATMENT, ¿POSSIBLY LEADING TO FATIGUE OF PICC AT ENTRY TO VESSEL¿.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6308502 ↗
• MalfunctionFeb 7, 2017Crack; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PICC WAS PLACED ON (B)(6) 2016, FOR CHEMOTHERAPY. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2017, TO DISCONNECT THE INFUSOR BOTTLE. IT WAS STATED THAT WHILE FLUSHING THERE WAS LEAKING AT THE SITE. THE PICC WAS REMOVED IN THE CLINIC BY THE HCN; IT WAS ALLEGED THAT THERE WAS A CRACK AT APPROXIMATELY 2CMS BELOW THE EXTERNAL MARKING. PATIENT STATED THAT THEY HAD NOT ADHERED TO THE ACTIVITY RESTRICTIONS AT ALL TIMES WHILE THE PICC WAS IN PLACE AND CONTINUED TO REMAIN ACTIVE WHILE RECEIVING TREATMENT, ¿POSSIBLY LEADING TO FATIGUE OF PICC AT ENTRY TO VESSEL.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6308501 ↗
• MalfunctionMar 11, 2016Hole In Material

  IT WAS REPORTED THAT A PICC HAD A HOLE IN IT AND IT HAD TO BE REMOVED. INFORMED BY ENGINEER TECH THAT SPLIT WAS DISCOVERED AT THE 40-41CM MARKING, INDICATING A SUBCUTANEOUS LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5496433 ↗