Turbo-Ject G34519Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002345195), received between Sep 20, 2017 and Jul 25, 2019 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8827933 ↗
• MalfunctionJun 28, 2019Separation Problem; Separation Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8745903 ↗
• MalfunctionMay 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR TREATMENT AT AN OUTPATIENT CLINIC. THE PATIENT WAS GIVEN 100ML INFUSION, FOLLOWED BY A 30ML FLUSH. WHEN THE FLUSH WAS STARTED, FLUID BEGAN TO LEAK OUT THE INSERTION SITE. UPON REMOVAL OF THE PICC LINE, "A SMALL TEAR DOWN THE LINE 5-6CM IN THE LINE UNDER THE SKIN" WAS FOUND. THE PICC LINE WAS INSERTED ON (B)(6) 2019. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655679 ↗
• MalfunctionMay 24, 2019Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639682 ↗
• InjuryMay 1, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8568835 ↗
• InjuryDec 5, 2018Material Separation; Material Separation

  IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC PLACED ON (B)(6) 2018 WAS FOUND FRACTURED WHERE THE LINE JOINS THE HUB. THE DEVICE WAS BEING USED TO DELIVER LONG TERM ANTIBIOTICS. THE DEVICE WAS REMOVED ON (B)(6) 2018 AND A SECOND PICC LINE, REPORTED ON MEDWATCH 1820334-2018-03538, WAS PLACE VIA WIRE EXCHANGE ON (B)(6) 2018. AS REPORTED, THE PATIENT REQUIRED SUSPENSION OF TREATMENT WHILE THE DEVICE WAS REMOVED AND REPLACED. THIS REPORT IS RELATED TO MDR'S: 1820334-2018-03538 AND 1820334-2018-03537 AS THEY INVOLVE THE SAME PATIENT.

  Patient problems: No Code Available

  MAUDE report 8135414 ↗
• InjuryDec 5, 2018Material Separation; Material Separation

  IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC USED AS A TUNNELED CVC WAS PLACED ON (B)(6) 2018 AND FOUND FRACTURED ON (B)(6) 2018. THE FRACTURE LOCATION WAS REPORTED TO BE WHERE THE TUBING JOINS THE HUB. THE DEVICE WAS USED TO DELIVER CONTINUOUS LONG TERM TPN POST STORMY NEONATAL COURSE. THE DEVICE WAS CONNECTED TO A NEUTRAL VALVE THAT WAS CHANGED EVERY EIGHT (8) DAYS WITH DRESSING. THE TPN LINE WAS CHANGED EVER FOUR (4) DAYS. THE PATIENT IS SAID TO HAVE NORMAL ACTIVITY BUT POOR VASCULATURE AND ACCESS. THE DEVICE WAS SECURED BY MEANS OF A SECURACATH, WITH SECONDARY SECUREMENT BY BORDERED TEGADERM AND INFUSION LINE SECUREMENT TO PATIENT'S CLOTHING. AS REPORTED, THE PATIENT WAS PUT UNDER A GENERAL ANESTHETIC FOR DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: No Code Available

  MAUDE report 8135158 ↗
• InjuryJan 12, 2018Crack; Crack

  THE INTERNATIONAL CUSTOMER REPORTED THAT TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS CRACKED. THE LINE HAD ORIGINALLY BEEN IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, OPACIFICATION OF THE PRODUCT WAS NOTED, WHICH WAS ATTRIBUTED BY THE CUSTOMER TO A LACK OF REFLUX. DIFFUSION WAS OBSERVED ON THE SURFACE, WHICH THE CUSTOMER POSTULATED MAY HAVE BEEN DUE TO A CRACK IN THE PICC LINE. ON (B)(6) 2017, THROMBOSIS OF THE LINE WAS OBSERVED, WHICH BEGAN AT THE INITIAL PORTION OF THE LEFT SUBCLAVIAN VEIN. THE PICC LINE WAS ULTIMATELY REMOVED ON (B)(6) 2017. THE LINE WAS REPLACED WITH A MID LINE WITH AN INDICATION OF PASSING A TAXOTERE CHEMOTHERAPY HALF-DOSE. THE COMPLAINT PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL ONGOING.

  Patient problems: No Code Available

  MAUDE report 7188633 ↗
• InjuryOct 3, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AT AN UNSPECIFIED POINT IN TIME FOLLOWING IMPLANTATION OF THE TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC, A BREAK WAS DISCOVERED JUST UNDER THE PORT AREA OF THE DEVICE. THE PRODUCT ISSUE ULTIMATELY NECESSITATED THE EXCHANGING OF THE LINE. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE NOT REPORTED. FURTHER INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. THE DEVICE IS REPORTEDLY NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6910650 ↗
• InjurySep 20, 2017Leak/Splash

  THE CATHETER WAS LEAKING JUST AFTER THE HUB, THIS WAS NOTED APPROXIMATELY THREE WEEKS AFTER PLACEMENT. THE LINE WAS ONLY USED TO PROVIDE ANTIBIOTICS.

  Patient problems: No Code Available

  MAUDE report 6879039 ↗