PowerPICC CK000820Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741152573), received between May 9, 2019 and Jun 16, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 16, 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.

• MalfunctionJun 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LINE LEAKING AFTER INSERTION." ADDITIONAL INFORMATION RECEIVED 06/01/2022: THIS WAS LEAKING FROM THE HUB. THE LEAKING WAS IDENTIFIED DURING THE INSERTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714638 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED " PURPLE LUMEN LEAKING AT HUB, CHANGED NEEDLELESS CONNECTORS BUT STILL LEAKED. WHEN FLUSH CONNECTED DIRECTLY TO HUB, NO LEAKING. 'VAT IDENTIFIED ON SUNDAY THAT LINE HAD BEEN LEAKING SINCE PLACEMENT ON (B)(6)." ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO WAS THE CATHETER REMOVED? YES WAS A NEW CATHETER PLACED? YES, CATHETER WAS EXCHANGED (B)(6) 2022 WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH. WAS THERE ANY PATIENT HARM REPORTED? NO. IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. WHAT THEY¿RE BEING TREATED FOR: S/P EX LAP AND ECF TAKEDOWN, END ILEOSTOMY (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118379 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "5FR DUAL POWERPICC LEAKING AT PURPLE HUB." ADDITIONAL INFORMATION RECEIVED 04/04/2022: ON DAY 3 OF INSERTION (B)(6) 2022), RN NOTED LEAK ON THE CONNECTION OF THE HUB AND NEEDLELESS CONNECTOR OVER THE PURPLE LUMEN DURING INFUSION. MULTIPLE NEEDLELESS CONNECTORS WERE CHANGED OVER THE PURPLE LUMEN BUT ALL WERE LEAKING. RED LUMEN DID NOT HAVE ANY ISSUES. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH PLACEMENT DATE: (B)(6) 2022, EXPLANT DATE: (B)(6) 2022, WAS THE PRODUCT USED ON A PATIENT? YES WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118266 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE DID FIND THAT BAXTER NEEDLELESS CONNECTOR (10) UR21I17075 LEAKED BUT WHEN CHANGED TO (10) UR21K30026 LINE WAS NOT LEAKING. IT WAS CHECKED THE NEXT MORNING PRIOR TO DISCHARGE AND CATHETER WAS THEN FOUND TO BE LEAKING SO WAS EXCHANGED PRIOR TO DISCHARGE." WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? CPN ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO WAS THE CATHETER REMOVED? YES WAS A NEW CATHETER PLACED? CATHETER WAS EXCHANGED ON (B)(6) 2022 WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH WAS THERE ANY PATIENT HARM REPORTED? NO WHAT THEY¿RE BEING TREATED FOR: ADENOCARCINOMA, HISTORY WHIPPLE PRESENTS WITH ABD PAIN/ NAUSEA AND VOMITING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118264 ↗
• MalfunctionApr 8, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THE PURPLE LUMEN FOUND LEAKING. INTERESTINGLY WE DID FIND THAT BAXTER NEEDLELESS CONNECTOR (10) (B)(4) LEAKED BUT WHEN CHANGED TO (10) (B)(4) LINE WAS NOT LEAKING. IT WAS CHECKED THE NEXT MORNING ((B)(6)) AND WAS OK THEN IT WAS CHECKED AGAIN ON (B)(6) IT DID NOT LEAK WITH FLUSH BUT NURSE LEFT AND CAME BACK AFTER ABOUT AND HOUR AND FOUND A DROP OF FLUID AT CONNECTION OF NEEDLELESS CONNECTOR AND LUMEN. ADDITIONAL INFORMATION RECEIVED 03/24/2022: WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? CPN. ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. WAS THE CATHETER REMOVED? YES WAS A NEW CATHETER PLACED? EXCHANGED (B)(6). WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK. WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054017 ↗
• MalfunctionApr 7, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "WE HAVE A PICC THAT WE HAD TO EXCHANGE BECAUSE THE PURPLE LUMEN WAS LEAKING AT THE HUB WHEN A NEEDLELESS CONNECTOR WAS ATTACHED. WE TRIED BOTH BAXTER AND RHYMED NEEDLELESS CONNECTORS AND NO MATTER HOW TIGHT WE SCREWED ON THE NEEDLELESS CONNECTOR IT WAS STILL LEAKING. (NO ISSUES WITH RED LUMEN) WHEN NEEDLELESS CONNECTOR WAS REMOVED AND SYRINGE ATTACHED DIRECTLY TO THE LINE THERE WAS NO LEAKING. LEAKS FROM HUB CONNECTION TO NEEDLELESS CONNECTOR." ADDITIONAL INFORMATION RECEIVED 03/24/2022 A DETAILED DESCRIPTION OF THE EVENT: PURPLE LUMEN LEAKING. VAT TIGHTENED CONNECTOR AND LEAKING STOPPED. WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? CPN ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO WAS THE CATHETER REMOVED? CATHETER REMOVED (B)(6)THERAPY COMPLETED WAS A NEW CATHETER PLACED? NO WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044352 ↗
• MalfunctionApr 1, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "A NEW PICC PLACED WAS LEAKING FROM HUB. WE RE-WIRED IT THE NEXT DAY." ADD INFO RCVD 03/18/2022: A 5FR DL PICC LINE WAS INSERTED OVER L BASILIC VEIN, UPON SUCCESSFUL 3CG CONFIRMATION OF TIP AND SECUREMENT DEVICE ATTACHED (USED SECURACATH), CAPS WERE ATTACHED OVER BOTH LUMENS AND FLUSHED. NO ISSUES WERE NOTED OVER RED LUMEN WHEN CAP AND FLUSHING WAS PERFORMED, ON PURPLE LUMEN, NO ISSUES WERE ALSO IDENTIFIED WHEN FLUSHING THE LUMEN (DIRECT NSS PREFILLED SYRINGE TO LUMEN) BUT WHEN CAP WAS APPLIED AND FLUSHED IT THERE WAS A NOTED LEAK OVER THE CONNECTION OF THE CAP AND PICC LUMEN. THEY ATTEMPTED TO CHANGE EXTERNAL CAPS MULTIPLE TIMES TO ASSESS AND SEE IF IT WAS THE CAPS BUT SAME THING HAPPENED AND WHEN SWITCHED BACK TO DIRECT NSS PREFILLED SYRINGE AND PICC LUMEN NO LEAK WAS NOTED. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH. EXPLANT DATE: (B)(6) 2022 PICC LINE WAS NOT USED AND WAS PLANNED TO BE REPLACED BY REWIRE BUT PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979800 ↗
• MalfunctionJan 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC BEGAN TO LEAK FROM THE HUB CONNECTION THE PURPLE LUMEN AT THE CONNECTION TO THE TUBING THAT HOUSES THE CLAMP ON DWELL DAY 9 AND REQUIRED REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9541211 ↗
• MalfunctionMay 9, 2019Material Rupture

  IT WAS REPORTED THAT 5 FR D/L POWERPICC RUPTURED DURING POWER INJECTION. IT WAS DOCUMENTED THAT I HAD A POSITIVE BLOOD RETURN AND EASY FLUSH OVERNIGHT, AS WELL AS JUST PRIOR TO THE INJECTION. CATHETER WAS SECURED WITH A SECURACATH. THERE WERE 3 CM EXTERNAL AND THE CATHETER RUPTURED AT 2 CM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596726 ↗