Turbo-Ject G03786Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002037861), received between Feb 1, 2017 and Sep 19, 2017 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2017Break

  UPON CHECKING THE SHEATH TIP, IT WAS NOTED TO BE BROKEN. THE DOCTOR SHEATH DEFECT WAS DISCOVERED BEFORE THE PROCEDURE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877045 ↗
• MalfunctionSep 18, 2017Fluid/Blood Leak

  THE COMPLAINANT REPORTED THAT THERE WAS A MICRO LEAK AT THE HUB OF THE CATHETER. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873960 ↗
• MalfunctionMay 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE. THE CUSTOMER REPORTS THAT "THE PATIENT VEIN CONDITION WAS NOT GOOD AND TORTUOUS." THE PHYSICIAN HAD DIFFICULTY INSERTING THE WIRE GUIDE BUT WAS NOT ABLE TO INSERT THE CATHETER. THE PHYSICIAN REMOVED THE WIRE GUIDE AND OBSERVED THAT THE SOFT TIP OF THE WIRE WAS BROKEN. THE PHYSICIAN WAS NOT ABLE TO USE THE PICC LINE. NO ADVERSE PATIENT CONSEQUENCES ARE REPORTED. THE DEVICE WAS RECEIVED FOR EVALUATION. NO UNINTENDED SECTION OF THE DEVICE REMAINED WITHIN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585080 ↗
• InjuryFeb 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT THE GUIDE WIRE WAS INADVERTENTLY CONTAMINATED WHILE PREPARING FOR USE. THE CONTAMINATED DEVICE WAS REMOVED FROM THE STERILE FIELD AND DISCARDED. A REPLACEMENT GUIDE WIRE WAS OBTAINED AND THE PROCEDURE COMPLETED WITHOUT INCIDENT. THERE ARE NO REPORTS OF ANY ADVERSE EVENT. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. ACCORDINGLY, THIS REPORT DOES NOT MEET REPORTING CRITERIA AS DEFINED UNDER 21 CFR PART 803.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6294134 ↗