Turbo-Ject G03785Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002037854), received between May 19, 2016 and Sep 18, 2020 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Patient Involvement

  MAUDE report 10554309 ↗
• InjurySep 16, 2019Break; Break

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9070340 ↗
• InjuryApr 19, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8531173 ↗
• MalfunctionApr 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE WIRE GUIDE IN A TURBO-JECT STANDARD POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS UNABLE TO BE REMOVED FROM THE PEEL-AWAY. THE WIRE GUIDE RESEMBLED A PIGTAIL. TO DATE, ADDITIONAL INFORMATION REGARDING THE DEVICE AND PATIENT HAS NOT BEEN MADE AVAILABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441509 ↗
• InjuryDec 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT AIR BUBBLES APPEARED IN THE TUBING OF THE TURBO-JECT STANDARD POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE. THE BUBBLES WERE DESCRIBED BY THE CUSTOMER AS BEING BETWEEN THE MANIFOLD AND THE VALVE OF THE DEVICE. THE CUSTOMER WAS CONCERNED THAT THE AIR BUBBLES PRESENTED A RISK OF AN AIR EMBOLISM, AND THE DEVICE WAS CHANGED OUT AS A RESULT. THE COMPLAINT DEVICE WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017. THE COMPLAINT DEVICE WAS NOT SAVED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7108054 ↗
• InjurySep 26, 2017Leak/Splash

  A PICLINE IS FITTED FOR A SKIN GRAFT PATIENT. DURING THE ADMINISTRATION OF ANTIBIOTIC PRODUCT, THE STAFF NOTICED A LEAKAGE AT THE JUNCTION OF THE CONNECTOR AND THE CATHETER PIPE. THE ANTIBIOTIC TREATMENT WAS NOT COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6893095 ↗
• MalfunctionSep 25, 2017Break; Material Separation

  THE CUSTOMER REPORTED THAT THE YELLOW HUB OF THE INTRODUCER BROKE AND WAS SEPARATED WHEN THE PHYSICIAN WANTED TO OPEN THE PEEL-AWAY SHEATH. THE REST OF THE DEVICE WAS ALREADY IN THE PATIENT, BUT THE PHYSICIAN WAS ABLE TO CAREFULLY REMOVE IT. NO PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890250 ↗
• InjurySep 21, 2017Leak/Splash

  THE PICC WAS DISCOVERED TO BE LEAKING FROM JOINT OF LUER HUB AND CLEAR LUMEN. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE - A REPLACEMENT PICC LINE WAS INSERTED. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6882806 ↗
• InjurySep 21, 2017Leak/Splash

  THE PICC WAS DISCOVERED TO BE LEAKING FROM JOINT OF LUER HUB AND CLEAR LUMEN. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE - A REPLACEMENT PICC LINE WAS INSERTED. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6882569 ↗
• MalfunctionSep 19, 2017Fluid/Blood Leak

  A FEW DAYS AFTER THE PICC LINE PLACEMENT, THE CUSTOMER NOTED A LEAK ON THE CATHETER BETWEEN THE SKIN AND THE PURPLE PART OF THE CATHETER. THE PICC LINE WAS REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6877126 ↗
• MalfunctionSep 19, 2017Entrapment of Device; Material Frayed; Failure to Advance; Physical Resistance

  IT WAS REPORTED THAT WHEN THE PICC GUIDEWIRE HAD BEEN PLACED APPROXIMATELY 15CM INTO THE PATIENT, THE OPERATOR FELT A RESISTANCE AND THE WIRE WOULD NO LONGER ADVANCE. SHE ATTEMPTED TO REMOVE THE WIRE, BUT IT CAUGHT IN THE NEEDLE AND BEGAN TO FRAY. THE NEEDLE AND WIRE HAD TO BE REMOVED TOGETHER. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6876341 ↗
• MalfunctionSep 19, 2017Split; Torn Material

  THE PEEL-AWAY SHEATH TORE AND THE SHEATH WAS NOTED TO HAVE NICKS, SPLITS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875963 ↗
• MalfunctionSep 19, 2017Device Operates Differently Than Expected

  IT WAS REPORTED DURING THE PICC PLACEMENT PROCEDURE (ABOVE THE BEND OF THE ARM -THE CREASE AT ELBOW FLEXURE), AFTER REMOVING THE NEEDLE AND INSERTING THE SHEATH (PEEL AWAY INTRODUCER), THE SHEATH OF THE PEEL AWAY WRINKLED. AS A RESULT, ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE PROCEDURE. DEVICE IMAGING IDENTIFIED HANGNAIL (SPLIT) DAMAGE AT THE DISTAL TIP OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875637 ↗
• MalfunctionSep 19, 2017Split; Wrinkled; Material Deformation

  IT WAS REPORTED DURING THE PLACEMENT PROCEDURE (BEND OF THE ARM- THE CREASE AT ELBOW FLEXURE), AFTER REMOVING THE NEEDLE AND INSERTING THE SHEATH (PEEL AWAY INTRODUCER), THE SHEATH OF THE PEEL AWAY WRINKLED. AS A RESULT, ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE PROCEDURE. DEVICE IMAGING IDENTIFIED HANGNAIL (SPLIT) DAMAGE AND BULGING AT THE DISTAL TIP OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875480 ↗
• MalfunctionSep 18, 2017Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THE PICC LINE TRAY IN THE BOTTOM RIGHT HAND CORNER WAS BROKEN, COMPROMISING THE STERILITY OF THE SUPPLIED COMPONENTS. DOCUMENTATION DOES NOT IDENTIFY THIS BREAK CAN BE EASILY SEEN.

  Patient problems: No Patient Involvement

  MAUDE report 6873215 ↗
• MalfunctionSep 14, 2017Material Integrity Problem

  WHEN TRYING TO TAKE THE GUIDE OUT, THE DISTAL END DECOMPOSED ITSELF. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 6865548 ↗
• MalfunctionSep 14, 2017Entrapment of Device; Peeled/Delaminated

  DURING INSERTION, THE PEELWAY SHEATH PEELED BECAUSE IT IS CAUGHT IN THE PATIENT'S SKIN. WHEN THE DEVICE WAS REMOVED NICKS/HANGNAILS WERE NOTED ON THE TIP OF THE DEVICE. A NEW PRODUCT USED TO COMPLETE THE PROCEDURE.

  Patient problems: Tissue Damage

  MAUDE report 6864831 ↗
• InjuryMay 24, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE WAS IMPLANTED ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE DEVICE BEGAN TO LEAK AT THE BASE ON (B)(6) 2017. THE CATHETER WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW DEVICE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. THE PATIENT WAS DISCHARGED TO HOME.

  Patient problems: No Code Available

  MAUDE report 6588339 ↗
• MalfunctionFeb 27, 2017Leak/Splash; Leak/Splash

  INITIAL INFORMATION FOR THIS REPORT WAS RECEIVED FROM THE NATIONAL AGENCY FOR THE SAFETY OF MEDICINE AND HEALTH PRODUCTS (ANSM) OF (B)(6). INTERNATIONAL CUSTOMER REPORTED THAT APPROXIMATELY 20 MLS OF UNSPECIFIED CHEMOTHERAPY MEDICATION LEAKED FROM A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE CONDITIONS AND CIRCUMSTANCES INCLUDING THE DEVICE IMPLANTATION DATE AND DURATION OF IMPLANTATION WERE NOT PROVIDED. THE LEAK WAS OBSERVED AT THE LEVEL OF THE ANTI-REFLUX VALVE. THE PICC LINE LEAK WAS SEALED ("PLASTER" ) AND THE ANTI-REFLUX VALVE DISCONNECTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE NOT SUCCESSFUL. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6361069 ↗
• InjuryOct 12, 2016Crack; Crack

  IT WAS REPORTED THAT DURING A BASILIC VEIN PROCEDURE, A PICC LINE HAD A CRACK. THE CRACK WAS NOTICED WHEN THE USER WANTED TO CONNECT THE PICC LINE TO THE CHILD. THE CRACK WAS BETWEEN THE 'TUBING' AND THE CATHETER'S END MAKING IT IMPOSSIBLE TO INFUSE THE CHILD. THEREFORE, THE PICC LINE HAD TO BE RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6023936 ↗
• InjuryMay 19, 2016Material Separation; Material Separation

  A PICC LINE WAS PLACED ON (B)(6) 2016 FOR TREATMENT. WHILE THE PATIENT WAS AT HOME, THE PICC LINE TORE APART AT THE CAP LEVEL. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PICC LINE WAS CHANGED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 5666959 ↗