Turbo-Ject G55885Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002558854), received between Dec 15, 2016 and May 9, 2018 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED ON MEDWATCH 1820334-2018-00671 A PATIENT WAS DIAGNOSED WITH THROMBOSIS VIA ULTRASOUND. THIS REPORT CAPTURES A STOCK SAMPLE RETURNED BY THE CUSTOMER FOR EVALUATION. ONE UNOPENED TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET WAS RETURNED AND TESTED. FUNCTIONAL TESTING FOUND LOOSE OR EMBEDDED PLASTIC WAS NOT FLUSHED/REMOVED FULLY DURING THE PRODUCTION PROCESS CAUSING LINE OCCLUSION.

  Patient problems: No Patient Involvement

  MAUDE report 7498252 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, FOLLOWING THE UNEVENTFUL PLACEMENT OF THE TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET INTO THE PATIENT'S RIGHT BASILICA VEIN ON (B)(6) 2018, THE PATIENT LATER RETURNED TO THE HOSPITAL ON (B)(6) 2018 WITH PAIN IN THE RIGHT ARM. A THROMBOSIS WAS DIAGNOSED VIA ULTRASOUND. THE PHYSICIAN TREATED THE CONDITION BY ADMINISTERING MEDICATION FOR THE CLOTTING (CLEXANE). THE CUSTOMER REPORTED THAT THE PRIMARY INFUSIONS THROUGH THE LINE WERE PARENTERAL FEEDING PRODUCTS AND NACL 0.9%, AND THE PATIENT HAD A NORMAL ANATOMY AND STATUS. THE PHYSICIAN OPTED TO LEAVE THE PICC LINE IN THE PATIENT; ACCORDINGLY, THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Code Available; Thrombosis

  MAUDE report 7372113 ↗
• InjuryJan 17, 2018Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT THE PURPLE HUB OF THE TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SEPARATED FROM THE TUBING PORTION OF THE DEVICE. THIS ULTIMATELY RESULTED IN THE NEED TO REMOVE AND REPLACE THE CATHETER IN AN ADDITIONAL LINE REPLACEMENT PROCEDURE. IT REPORTEDLY APPEARED TO BE A PARTIAL SEPARATION ONLY, AS THE DEVICE WAS NOT COMPLETELY BROKEN INTO TWO PIECES. THE HUB ALSO APPEARED TO BE FREE OF CRACKS, DESPITE THE SEPARATION FROM THE TUBING. THE HUB WAS USED FOR INFUSIONS OF TOTAL PARENTERAL NUTRITION, INTRALIPID'S, AND LACTATED RINGERS SOLUTION. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED AT THIS TIME. THE CUSTOMER HAS STATED THEY WILL NOT BE RETURNING THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 7201997 ↗
• MalfunctionSep 26, 2017Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER WAS LEAKING AT THE HUB/CATHETER JUNCTION. A REPLACEMENT WAS PERFORMED WITH NO HARM TO THE PATIENT, AND NO PART OF THE DEVICE WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6895041 ↗
• InjurySep 26, 2017Fluid/Blood Leak

  THE CATHETER WAS LEAKING AT THE HUB JUNCTION, REQUIRING THE PATIENT TO HAVE A DEVICE EXCHANGE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6893468 ↗
• InjurySep 26, 2017Leak/Splash

  THE DEVICE WAS LEAKING AT THE HUB / CATHETER JUNCTION. THE PATIENT HAD TO COME BACK 1 WEEK LATER TO RE-WIRE THE PICC LINE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6893384 ↗
• InjurySep 26, 2017Detachment Of Device Component

  AFTER THE PICC WAS PLACED, THE PATIENT WENT BACK TO THE HOLDING AREA. A FEW MINUTES LATER, THE NURSE FOUND THAT THE HUB HAD DETACHED FROM THE CATHETER, REQUIRING THE ANOTHER PROCEDURE TO REWIRE THE PICC. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6893175 ↗
• MalfunctionSep 25, 2017Fluid/Blood Leak

  THE CATHETER LEAKED AT THE HUB/CATHETER JUNCTION. THE DEVICE WAS REPLACED, BUT IT IS UNKNOWN IF THIS OCCURRED DURING THE INITIAL IMPLANTATION PROCEDURE OR LATER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892531 ↗
• InjurySep 19, 2017Crack

  THE CUSTOMER REPORTED THAT THE PICC CRACKED AT THE JUNCTION BETWEEN THE CATHETER AND HUB DURING A CONTINUOUS INFUSION. THE PICC LINE HAD TO BE REPLACED, BUT THERE WERE NO INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE. NO PART OF THE COMPLAINT DEVICE WAS LEFT IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6877539 ↗
• MalfunctionSep 18, 2017Leak/Splash

  THE CUSTOMER REPORTED THAT THE CATHETER WAS LEAKING AT THE HUB/CATHETER JUNCTION. THE DEVICE WAS REPLACED WITH A NEW CATHETER. NO PART OF THE COMPLAINT DEVICE WAS LEFT IN THE PATIENT. THERE WERE NO INJURIES TO THE PATIENT OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872935 ↗
• InjurySep 18, 2017Leak/Splash

  THERE WAS LEAKING AT THE HUB OF THE CATHETER AT THE JUNCTION OF LINE. THE LINE WAS REPLACED. THE REPORTER STATES THAT THE PATIENT DID NOT HAVE ANY OTHER ADVERSE EVENTS IN RELATION TO THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6872541 ↗
• InjurySep 15, 2017Detachment Of Device Component

  THE HUB FELL OFF THE PICC AFTER BEING IN USE FOR 23 DAYS, REQUIRING THAT THE PICC BE REMOVED AND REPLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6869063 ↗
• MalfunctionSep 15, 2017Unraveled Material; Mechanical Jam

  THE CUSTOMER REPORTED THAT WHILE TRYING TO WITHDRAW THE NEEDLE, THE WIRE GUIDE JAMMED AND BEGAN UNRAVELING. THE NEEDLE AND WIRE WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO SERIOUS INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868867 ↗
• InjurySep 15, 2017Leak/Splash

  THE DEVICE IS LEAKING NEAR THE HUB CATHETER JUNCTION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PICC REWIRE PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6868448 ↗
• MalfunctionFeb 23, 2017Break; Break

  CUSTOMER REPORTED THAT A PREVIOUSLY IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE CRACKED AT THE HUB AND CATHETER JUNCTION. THE DURATION OF IMPLANTATION WAS NOT PROVIDED. THE CIRCUMSTANCES AND CONDITIONS AT THE TIME OF THE EVENT ARE NOT KNOWN. THE REPORTER OPINES THAT THE ATTACHMENT AND TWISTING MOTION OF A HUB CLEANING DEVICE EMPLOYED BY THE NURSING STAFF MAY BE A CAUSAL FACTOR IN THE EVENT. NO FURTHER PATIENT, PROCEDURE OR EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353015 ↗
• InjuryDec 15, 2016Material Separation; Material Separation

  IT WAS REPORTED A "PICC LINE WAS PLACED ON (B)(6) 2016 AND ON (B)(6) 2016 IT WAS NOTED THAT THE HUB WAS COMPLETELY DETACHED FROM THE CATHETER. AT THE TIME OF THIS REPORT THE PHYSICIAN HAS NOT STATED HOW THEY WILL PROCEED. CURRENTLY THE CUSTOMER DOES NOT HAVE A PICC LINE IN PLACE." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED ON 12/09/2016: THE PATIENTS' PICC LINE WAS NOT REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6178328 ↗