Turbo-Ject G03777Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00827002037779), received between Jun 23, 2016 and Dec 4, 2020 — classified as 13 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2020Fitting Problem; Fitting Problem

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6)2021, IT WAS REPORTED THAT THE LINE WAS PLACED TO PROVIDE REGULAR CHEMOTHERAPY FOR THE TREATMENT OF LEUKEMIA, WHEN THE LEAK WAS DISCOVERED, THE PATIENT WAS TAKEN FOR BLOOD TESTS. NOTHING WAS IN PLACE ON THE PATIENT EXCEPT FOR THE CATHETER. THE DEVICE WAS SECURED TO THE PATIENT WITH A STATLOCK. THE PATIENT'S ACTIVITY LEVEL WAS REPORTED TO BE INACTIVE. SOME OF THE MEDICATIONS THAT WERE INFUSED THROUGH THE LINE INCLUDED CHEMOTHERAPY, ANTIBIOTIC THERAPY, HYDRATION AND PARENTERAL NUTRITION. THE FAILED HUB WAS USED FREQUENTLY, AS THE PATIENT WAS UNDERGOING CHEMOTHERAPY, WITH REGULAR SAMPLES TAKEN AT LEAST ONCE A WEEK FOR BIOLOGICAL ASSESSMENTS. THE DEVICE WAS FLUSHED WITH A SOLVENT USED FOR CHEMOTHERAPY, EITHER G5% OR NACL 0.9%.

  Patient problems: No Code Available; No Information

  MAUDE report 10949675 ↗
• InjuryAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC WAS LEAKING AT THE HUB. THE PICC WAS INITIALLY PLACED ON (B)(6) 2020. THE PATIENT WAS RECEIVING AN INFUSION OF PARENTERAL NUTRITION WHEN THE NURSE NOTICED THE PRODUCT WAS LEAKING AT THE VIOLET HUB. A NEW PICC LINE WAS PLACED ON (B)(6) 2020. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10451055 ↗
• MalfunctionOct 4, 2019Material Frayed; Material Separation; Material Frayed; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158281 ↗
• InjuryMay 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8640468 ↗
• MalfunctionApr 4, 2018Stretched; Stretched

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER THE TURBO-JECT STANDARD POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE WAS OPENED, "THE GUIDE IN THE KIT WAS PULLED, LEAVING A DEFAULT TO BE SEEN ON THE COATING" (SIC). FURTHER CLARIFICATION INDICATED THE GUIDE IN CONTAINED IN THE KIT WAS STRETCHED REVEALING A DEFECT IN THE COATING. AS A RESULT, THE USE OF ANOTHER GUIDE WAS USED IN ORDER TO START THE PROCEDURE. THE CUSTOMER REPORTED THERE WAS NO SIGNIFICANT DELAY AND NO CLINICAL CONSEQUENCE TO THE PATIENT. THE COMPLAINT PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN BUT AS OF THE DATE OF THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7396758 ↗
• InjurySep 26, 2017Cut In Material

  THERE WAS A CUT IN THE BASE OF THE CATHETER AT THE BASE PART OF THE PICC LINE, IT WAS NOTED DURING A PERFUSION. THE PERFUSION WAS STOPPED AND THEY PLACED ANOTHER PICC IN THE FOLLOWING DAYS. 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 6893570 ↗
• MalfunctionSep 25, 2017Fluid/Blood Leak

  THE PICC-SET WAS IMPLANTED AND STARTED TO LEAK BETWEEN THE TUBE AND THE THREAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892347 ↗
• MalfunctionSep 25, 2017Fluid/Blood Leak

  THE PICC-SET WAS IMPLANTED AND STARTED TO LEAK BETWEEN THE TUBE AND THE THREAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892247 ↗
• InjurySep 25, 2017Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE PURPLE HUB OF THE PICC LINE SEPARATED FROM THE CATHETER TUBING, REQUIRING THE DEVICE TO BE REPLACED. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6890171 ↗
• MalfunctionSep 25, 2017Break

  THE CUSTOMER REPORTED THAT THERE WAS A CUT IN THE BASE OF THE CATHETER. THE PICC LINE WAS REMOVED. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890157 ↗
• InjurySep 21, 2017Leak/Splash

  LEAKAGE FOUND DURING FLUSHING FROM BETWEEN THE HUB AND THE LEG OF THE PICC. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE - THE PICC WAS REPLACED. NO ADVERSE OTHER EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6882520 ↗
• MalfunctionSep 21, 2017Fluid/Blood Leak; Particulates

  THE PICC LEAKED DURING AN ANTIBIOTIC INFUSION OVER THE WEEKEND. ON EXAMINATION OF THE DEVICE, THERE WERE CRYSTALLINE PARTICLES ON THE PURPLE HUB AND WHEN FLUSHED THERE WAS LEAKAGE PRESENT FROM BETWEEN THE PURPLE INJECTION HUB AND THE CLEAR TUBING. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882116 ↗
• InjurySep 20, 2017Device Dislodged or Dislocated

  THREE WEEKS AFTER THE PICC WAS INSERTED, THE PATIENT NOTED THAT THE PURPLE HUB CAP SNAPPED OFF AND THE PICC WAS 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 6879803 ↗
• InjurySep 19, 2017Leak/Splash; Material Rupture

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AFTER IMPLANTATION, THE PICC LINE WAS FOUND TO BE LEAKING FROM A RUPTURE BETWEEN THE CLEAR LUMEN AND UPPERMOST PLASTIC HUB. THE LINE HAD TO BE REPLACED. NO PART OF THE ORIGINAL DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6875382 ↗
• InjurySep 19, 2017Break; Leak/Splash

  THE CUSTOMER REPORTED THAT APPROXIMATELY 2.5 MONTHS AFTER IMPLANTATION, THEY HAD TO PERFORM A SECOND REPAIR OF A PICC LINE AFTER ITS VIOLET HUB BROKE OFF OF THE TUBING, RESULTING IN A LEAK. THE LINE WAS REPLACED WITH ANOTHER DEVICE. NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6875321 ↗
• MalfunctionSep 18, 2017Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PICC LINE APPEARED TO BE LEAKING AT THE HUB. THE PICC LINE WAS REMOVED AS INTENDED. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL SURGICAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6874151 ↗
• MalfunctionSep 15, 2017Break

  IT WAS REPORTED DURING THE PROCEDURE (ARM, BASILIC VEIN), WHEN THE PHYSICIAN WENT TO PEEL THE PEEL-AWAY SHEATH, THE WINGED HUB(S) OF THE INTRODUCER BROKE. AS A RESULT, IT WAS DIFFICULT TO PEEL THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868292 ↗
• MalfunctionSep 15, 2017Material Separation

  IT WAS REPORTED DURING HUMERAL VEIN ACCESS, AS A SECTION OF THE PEEL-AWAY SHEATH WAS PEELED, THE SHEATH SEPARATED FROM THE "YELLOW PART" (WINGED HUB). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868228 ↗
• MalfunctionSep 14, 2017Material Separation

  THE HUB OF THE PICC SEPARATED FROM THE LINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865702 ↗
• MalfunctionSep 14, 2017Insufficient Device Problem Information

  WHILE THE ANESTHETIST WAS INSERTING THE DILATOR FOR PERIPHERALLY INSERTED CENTRAL CATHETER INTO THE PATIENTS' ARM HE NOTED THAT THE DILATOR WAS BURRED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT, HOWEVER, THE PROCEDURE HAD TO BE STARTED AGAIN WITH A NEW DILATOR FROM THE PICC KIT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6864242 ↗
• InjuryJun 26, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PLACED ON AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTS THAT LEAKAGE WAS NOTED AS A RESULT OF A CRACK IN THE PICC LINE. THE HANDLING CONDITIONS AND CIRCUMSTANCES LEADING UP TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW DEVICE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6667000 ↗
• MalfunctionMay 2, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE IMPLANTED ON AN UNSPECIFIED DATE. THE PICC LINE BROKE AT THE JUNCTION OF THE CATHETER AND THE BASE. IT IS OPINED THAT THE DEVICE WAS EXPLANTED, HOWEVER NO FURTHER EVENT INFORMATION WAS PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DEVICE IS AVAILABLE FOR EVALUATION HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6537060 ↗
• InjuryMar 10, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS IMPLANTED IN A PATIENT ON AN UNSPECIFIED DATE IN (B)(6) 2016. THE DEVICE DEVELOPED A LEAK ON (B)(6) 2017 AND WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW LINE. THE CONDITIONS AND CIRCUMSTANCES SURROUNDING THE LEAK ARE NOT KNOWN. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6396544 ↗
• InjuryDec 21, 2016Split; Split

  IT WAS REPORTED THERE WAS A FISSURE IN THE TUBING OF THE PERIPHERALLY INSERTED CENTRAL CATHETER ( PICC) LINE. THE LINE WAS DISCOVERED TO BE CRACKED WHEN GETTING A BLOOD SAMPLE, THE PRESENCE OF AIR WAS NOTED WHEN ASPIRATING. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REPLACE THE PICC LINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6192637 ↗
• MalfunctionDec 15, 2016Break; Break

  DIFFICULTY WAS EXPERIENCED DURING USE OF THE PEEL AWAY INTRODUCER. IT WAS REPORTED THAT WHEN THE RADIOLOGIST TRIED TO PEEL IT, THE SMALL LUGS ON THE INTRODUCER BROKE, RESULTING IN THE RADIOLOGIST NOT BEING ABLE TO PROPERLY PEEL THE INTRODUCER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6176525 ↗