Turbo-Ject G03788Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002037885), received between Apr 9, 2015 and Jun 29, 2020 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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.

• MalfunctionJun 29, 2020Unsealed Device Packaging; Unsealed 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 10206830 ↗
• MalfunctionJan 17, 2020Material Frayed; Material Frayed

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

  Patient problems: No Patient Involvement

  MAUDE report 9603327 ↗
• InjuryJan 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT ULTRASOUND GUIDANCE WAS USED WHEN INTRODUCING THE WIRE GUIDE INTO THE NEEDLE. IT WAS ALSO NOTED THAT THE NEEDLE WAS ASPIRATED PRIOR TO WIRE GUIDE INSERTION, AND UPON REMOVAL OF THE WIRE, IT WAS WITHDRAWN THROUGH THE NEEDLE AND BECAME STUCK. THE WIRE WAS REMOVED FROM THE PATIENT SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8248474 ↗
• InjuryJun 28, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  FERNANDO R, LEE YJ, KHAN N, KAZMI F. DELAYED MIGRATION OF A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TO THE AZYGOS VEIN WITH SUBSEQUENT PERFORATION. BJR CASE REP 2016; 2: 20150315. THE BRITISH INSTITUTE OF RADIOLOGY PUBLISHED A CASE STUDY INVOLVING A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE DURING A DIAGNOSTIC LAPAROSCOPY. A CASE OF DELAYED MIGRATION OF A PICC INSERTED FOR TPN FROM THE SUPERIOR VENA CAVA INTO THE AZYGOS VEIN THAT WAS NOT INITIALLY RECOGNIZED ON CHEST RADIOGRAPHS OR CT SCAN. THIS SUBSEQUENTLY LED TO AZYGOS PERFORATION AND EXTRAVASATION OF THE TPN SOLUTION INTO THE MEDIASTINAL, PLEURAL AND PERICARDIAL SPACES. SEVERAL ANATOMICAL AND PROCEDURAL FACTORS PREDISPOSE TO PICC MIGRATION. IN THIS PATIENT, THE RISK OF PICC MIGRATION WAS INCREASED BY LEFT SIDED INSERTION AND VARIANT AZYGOS ANATOMY. IF A CURVE IN THE DISTAL TIP OF A PICC IS SEEN ON A FRONTAL CHEST RADIOGRAPH, AZYGOS MALPOSITION SHOULD BE SUSPECTED AND CONFIRMED WITH A LATERAL RADIOGRAPH, CT SCAN OR CATHETER INJECTION. THIS IS BECAUSE AZYGOS MALPOSITION INCREASES THE RISK OF VENOUS PERFORATION AND NEEDS TO BE CORRECTED. THE PATIENT REMAINED CLINICALLY STABLE AND MADE A GOOD RECOVERY. SHE WAS DISCHARGED

  Patient problems: Perforation

  MAUDE report 7644964 ↗
• MalfunctionSep 21, 2017Disconnection

  THE DOUBLE LUMEN PICC DISCONNECTED. 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 Consequences Or Impact To Patient

  MAUDE report 6882054 ↗
• MalfunctionSep 20, 2017Material Fragmentation; Migration or Expulsion of Device

  AFTER THE WIRE GUIDE WAS INSERTED, IT STARTED TO SHRED. 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 6879388 ↗
• MalfunctionSep 20, 2017Break; Detachment Of Device Component

  WEEKS AFTER PLACEMENT THE PATIENT NOTICED THAT THE HUB BROKE OFF. 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 6879344 ↗
• MalfunctionSep 19, 2017Material Integrity Problem

  IT WAS REPORTED THAT PER THE CUSTOMER, THE PEEL-AWAY SHEATH DIDN'T TEAR WELL. DEVICE IMAGING IDENTIFIED THE TIP OF THE SHEATH CONTAINED NICKS AND TEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877178 ↗
• MalfunctionSep 18, 2017Material Integrity Problem

  IT WAS REPORTED THE SURFACE OF THE PEEL AWAY SHEATH TIP IS NOT EVEN NOR SMOOTH. DEVICE IMAGING IDENTIFIED THE END OF THE SHEATH TIP CONTAINED AN ELEVATED SHARP POINT.

  Patient problems: No Information

  MAUDE report 6873075 ↗
• MalfunctionSep 18, 2017Difficult to Remove

  IT WAS REPORTED THE WIRE WAS DIFFICULT TO REMOVE THROUGH THE CATHETER AND ON INSPECTION THERE WAS A NOTICEABLE 'BUMP' APPROXIMATELY 5CM FROM THE DISTAL TIP OF THE WIRE. THE PATIENT REPORTEDLY EXPERIENCED ¿VASOVAGAL RESPONSE LIKE SYMPTOMS INCLUDING BRADYCARDIA" (MAGNITUDE UNSPECIFIED). THE PATIENT ALSO REPORTED ¿FEELING FUNNY¿. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. INSERTION: RIGHT SIDE BRACHIAL VEIN.

  Patient problems: Bradycardia

  MAUDE report 6871899 ↗
• MalfunctionSep 15, 2017Difficult to Remove; Sticking

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE RADIOLOGIST ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE CATHETER, BUT IT BECAME STUCK. THE WIRE AND CATHETER HAD TO BE REMOVED TOGETHER, AND THE PROCEDURE WAS PERFORMED WITH A DIFFERENT DEVICE. 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 6868961 ↗
• InjurySep 13, 2017Detachment Of Device Component; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER BEING IMPLANTED FOR APPROXIMATELY 1.5 MONTHS, THE DISTAL END OF THE PICC LINE SEPARATED, RESULTING IN A LEAK AND REQUIRING AN ADDITIONAL PROCEDURE TO REPLACE THE LINE WITH A DIFFERENT DEVICE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6861845 ↗
• InjurySep 13, 2017Crack; Leak/Splash

  TWO DAYS AFTER BEING PLACED THE PICC LINE WAS NOTED TO BE LEAKING SO THE PATIENT'S DRESSING WAS CHANGED. THREE DAYS AFTER THE DRESSING WAS CHANGED A CRACK WAS NOTICED IN THE WHITE PLASTIC AREA OF THE PICC LINES AND THE OPENING COULD NOT BE USED. DUE TO THE CRACKS THE PICC LINE WAS REPLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6861367 ↗
• InjurySep 13, 2017Leak/Splash; Torn Material

  THERE WAS A TEAR IN THE HARD PLASTIC WHICH CAUSE THE PICC LINE TO LEAK AT ITS OPENING. DUE TO THE LEAK, THE LINE WAS REPLACED AFTER 5 DAYS OF USE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Code Available

  MAUDE report 6860975 ↗
• MalfunctionAug 24, 2017Fracture; Kinked; Fracture; Kinked

  THE INTERNATIONAL CUSTOMER REPORTED THAT WHEN THE OPERATOR OF THE TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC WAS ATTEMPTING TO FIND AND ACCESS A VEIN, THE TIP OF THE WIRE GUIDE BROKE AND THE WIRE GUIDE COULD NO LONGER BE USED. ANOTHER WIRE GUIDE WAS USED TO PROCEED WITH THE PROCEDURE. THE CUSTOMER REPORTED THAT THIS INCIDENT HAD NO IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816235 ↗
• MalfunctionJul 1, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO PLACEMENT OF A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE FOR AN UNSPECIFIED INDICATION. THE TIP OF THE CATHETER SHEATH WAS OBSERVED TO BE DAMAGED UPON OPENING THE PACKAGE. THE DEVICE WAS NOT USED. A REPLACEMENT CATHETER WAS OBTAINED TO COMPLETE THE INTENDED PROCEDURE. THERE ARE NO ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6683450 ↗
• MalfunctionMay 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INTERNATIONAL CUSTOMER REPORTED THAT A DOUBLE LUMEN TURBO-JECT STANDARD POWER INJECTABLE PICC LINE WAS IMPLANTED IN A PATIENT FOR AN UNSPECIFIED INDICATION. THE IMPLANT APPROACH WAS NOT PROVIDED. PROPER TIP PLACEMENT WAS VERIFIED BY RADIOGRAPH. THE PHYSICIAN WAS NOT ABLE TO ASPIRATE THROUGH ONE OF THE TWO LUMENS WHILE TESTING THE DEVICE AFTER PLACEMENT. A FOLLOW-UP X-RAY SHOWED THAT THE TIP OF THE CATHETER APPEARED TO MIGRATE OR REGRESS CRANIALLY AND ABUT AGAINST A VESSEL WALL AT THE LEVEL OF THE TRACHEA. THIS ABUTMENT OF THE DEVICE TIP TO THE VESSEL PREVENTED ASPIRATION THROUGH THE CATHETER TIP. THE PICC LINE WAS EXCHANGED DURING THE SAME PROCEDURE AND THE TIP PLACEMENT CONFIRMED BY X-RAY THE TIP EXTENDED FURTHER CAUDALLY THAN THE INITIAL LINE PLACEMENT. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT INSERT THAT ACCOMPANIES THE DEVICE WARNS THE USER THAT "CATHETER TIP POSITION SHOULD BE MONITORED BY X-RAY ON A ROUTINE BASIS. PERIODIC LATERAL VIEW X-RAY IS SUGGESTED TO ASSESS TIP LOCATION IN RELATION TO VESSEL WALL." THE INSERT FURTHER CAUTIONS THAT "PATIENT MOVEMENT CAN CAUSE CATHETER TIP DISPL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6547013 ↗
• MalfunctionMar 23, 2017Fitting Problem; Fitting Problem

  INTERNATIONAL CUSTOMER REPORTED THAT THE CHECK-FLO VALVE OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) IS LOOSE. THE CUSTOMER INDICATED THAT THE ISSUE CAN RESULT IN POTENTIAL INFECTION AND AN INABILITY TO FULLY ADMINISTER TREATMENT DUE TO POSSIBLE LEAKAGE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS REPORT. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6427179 ↗
• MalfunctionJul 13, 2016Crack; Crack

  THE PATIENT HAD A PICC LINE PLACED FOR TOTAL PARENTERAL NUTRITION. ON TWO SEPARATE OCCASIONS, A CRACK IN THE LUMEN WAS NOTED JUST BENEATH THE HUB IN A SHORT SPACE OF TIME AFTER THEIR INSERTION (MDR# 1820334-2016-00605 AND 1820334-2016-00606). THE PICC LINES WERE REMOVED AND A NEW LINE WAS INSERTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 5791567 ↗
• MalfunctionJul 13, 2016Crack; Crack

  THE PATIENT HAD A PICC LINE PLACED FOR TOTAL PARENTERAL NUTRITION. ON TWO SEPARATE OCCASIONS, A CRACK IN THE LUMEN WAS NOTED JUST BENEATH THE HUB IN A SHORT SPACE OF TIME AFTER THEIR INSERTION (MDR# 1820334-2016-00606). THE PICC LINES WERE REMOVED AND A NEW LINE WAS INSERTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 5790202 ↗
• MalfunctionApr 9, 2015Component(s), broken

  AFTER PLACING A PICC LINE IN A (B)(6) FEMALE PT'S ARM, THE TUBING OF ONE OF THE TWO LINES BROKE. THE PICC LINE HAD BEEN PLACED ON (B)(6) 2015 FOR THE PASSAGE OF THE GLAUCIDIUM, AMIKACIN AND TIENAM. THE PT HAS MULTIPLE DISABILITIES WITH HER ARMS AND THE PICC LINE OFTEN RETRACTED. THE TUBING WAS THEREFORE, OFTEN BENT. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4687633 ↗