Turbo-Ject G23897Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002238978), received between Oct 25, 2016 and Sep 30, 2019 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Split” (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 16, 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.

• InjurySep 30, 2019Device Damaged by Another Device; Insufficient Device Problem Information; Device Damaged by Another Device; Insufficient Device Problem Information

  IT WAS REPORTED DURING AN INFUSION PROCEDURE ON (B)(6) 2019 THAT A COMPETITOR'S AMBULATORY INFUSION PUMP "RUPTURED" AND A COOK TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC WAS "DAMAGED". THE COMPETITOR'S PUMP WAS FILLED WITH "GOTTAGEN DRUG...AND PHYSIOLOGICAL SERUM" AND THE PUMP RUPTURED AT THE PATIENT'S HOME AFTER 10 MINUTES OF INFUSION. THE "TREATMENT WAS NOT DELIVERED" BUT AS "THE CENTRAL CATHETER OF THE PATIENT WAS DAMAGED, HE HAD TO UNDERGO SURGERY FOR THE REMOVAL AND REFITTING OF THE CATHETER". ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE FAILURE MODE OF THE COOK CATHETER AND THE INFUSION PROCESS, BUT IS UNAVAILABLE AT THIS TIME. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9135885 ↗
• InjuryAug 1, 2019Crack; Crack

  IT WAS REPORTED THAT THE PATIENT REQUIRED PLACEMENT OF A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC LINE IN THE ARM. FIVE WEEKS LATER, IT WAS NOTED THERE WAS A "PRODUCT LEAK IN THE PATIENT'S ARM CAUSING AN OEDEMATOUS ARM" WHICH NECESSITATED WITHDRAWAL OF THE PICC LINE. FOLLOWING WITHDRAWAL, IT WAS OBSERVED THAT THE PICC LINE WAS CRACKED. THE PATIENT REQUIRED A REPLACEMENT DEVICE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAD BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Edema; No Code Available

  MAUDE report 8850836 ↗
• MalfunctionApr 30, 2019Obstruction of Flow; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565944 ↗
• MalfunctionDec 19, 2018Complete Blockage; Use of Device Problem; Complete Blockage; Use of Device Problem

  IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC INSERTED ON (B)(6) 2018 WAS CUT BY THE PATIENT ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAD BEEN AGITATED AND CONFUSED FOR SEVERAL DAYS BUT THIS WAS NOT DUE TO USE OF THE COMPLAINT DEVICE. A BLOOD CLOT FORMED AND THE NURSE WAS UNABLE TO SUCTION THE CLOT. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. UPON REMOVAL, THE NURSE OBSERVED A "HERNIA" ON THE CATHETER. THE PATIENT WAS NOT RECEIVING CONTINUOUS INFUSIONS AND THE USER FACILITY DOES NOT LOCK PICC LINES AFTER FLUSHING. IT IS UNKNOWN IF THE COMPLAINT DEVICE WAS REPLACED BUT IT WAS REPORTED THAT THE PATIENT WAS RECEIVING DIRECT/BATCH INFUSIONS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8180088 ↗
• InjuryFeb 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT FOLLOWING THE REMOVAL OF THE TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER), THE PATIENT LATER REPORTED PAIN IN THEIR BREAST ON THE WEEKEND OF (B)(6) 2017 AND (B)(6) 2017. THE FOLLOWING WEEKEND OF (B)(6) 2017 AND (B)(6) 2017, THE PATIENT ARRIVED IN THE EMERGENCY ROOM WITH PREDOMINANT CERVICALGIA ON THE RIGHT RADIATING UP TO THE CLAVICULAR MEDIO RIGHT, AND SUSPECTED DEEP VEIN THROMBOSIS OF THE SUPERIOR VENA CAVA SYSTEM. THIS SUSPICION WAS CONFIRMED VIA ANGIOSCANNER. DEEP VEIN THROMBOSIS OF RIGHT AXILLARY VEIN, RIGHT SUBCLAVIAN VEIN, RIGHT VENOUS TRUNK, SUPERIOR VENA CAVA AND RIGHT INTERNAL JUGULAR VEIN WITHOUT CEREBRAL THROMBOPHLEBITIS WERE CONFIRMED. THE PATIENT REPORTEDLY HAD DEVELOPED MULTIPLE COLLATERALS ON THE RIGHT SIDE. THE PATIENT ALSO EXHIBITED PERMEABILITY OF THE LEFT VENOUS NETWORK, AND WAS FEBRILE (FEVER WITHOUT POINT OF CALL). THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR MONITORING AS WELL AS FOR THE INITIATION OF CURATIVE ANTICOAGULATION. THE PATIENT HAD ORIGINALLY BEEN TREATED FOR SYSTEMIC LUPUS ERYTHEMATOSUS BY RITUXIMAB. DAY 1 OF THE TREATMENT WAS (B)(6) 2017, AND DAY 15 OF THE TREATM

  Patient problems: Pain; Thrombosis

  MAUDE report 7234605 ↗
• MalfunctionDec 7, 2017Material Frayed; Material Frayed

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE OPERATOR WAS REMOVING THE GUIDEWIRE TO ADJUST THE NEEDLE INTO THE PATIENT'S VEINS WHILE EMPLOYING A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) AS PART OF A PROCEDURE, THE GUIDE WIRE WAS OBSERVED TO BE FRAYED. ANOTHER PICC LINE WAS USED TO CONTINUE THE PROCEDURE. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS OR ADDITIONAL PROCEDURES WERE NECESSITATED AS A RESULT OF THE PRODUCT MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE COMPLAINT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7098143 ↗
• MalfunctionSep 20, 2017Difficult to Remove; Failure to Advance

  DURING INSERTION THE WIRE BECAME STUCK AND COULD NOT ADVANCE OR BE REMOVED FROM THE CATHETER. THE DEVICE AND WIRE WERE REMOVED TOGETHER AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6878897 ↗
• MalfunctionSep 19, 2017Hole In Material

  THE DOCTOR PURGED THE CATHETER AND FLUSHED IT. THE DOCTOR REALIZED THAT THE CATHETER WAS PIERCED AND THE HOLE WAS IN THE GRADUATION AT 20.5CM. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT, SO NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877171 ↗
• InjurySep 14, 2017Fluid/Blood Leak; Split; Fluid/Blood Leak; Split

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER IMPLANTATION AND DURING USE OF THE TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER), THE PURPLE HUB SPLIT AND A LEAKAGE RESULTED. THIS NECESSITATED THE REMOVAL AND REPLACEMENT OF THE PICC LINE. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE NOT REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6864189 ↗
• MalfunctionSep 13, 2017Kinked

  IT WAS REPORTED DURING THE PICC LINE PLACEMENT PROCEDURE, A KNOT WAS OBSERVED AT THE TIP OF THE MICRO WIRE GUIDE. AS A RESULT, THE WIRE GUIDE COULD NOT BE INSERTED INTO THE NEEDLE. THE DEVICE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861424 ↗
• MalfunctionSep 13, 2017Difficult to Insert

  IT WAS REPORTED AFTER PUNCTURE, THE WIRE GUIDE COULD NOT BE INSERTED INTO THE NEEDLE DUE TO THE PRESENCE OF A KNOT AT THE WIRE GUIDE'S EXTREMITY. A NEW SET WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861047 ↗
• InjuryAug 10, 2017Split; Split

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTS THAT THE VIOLET PORTION OF THE VALVE WHERE THE INJECTION PRESSURE IS MARKED IS SPLIT RESULTING IN LEAKING. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT ARE NOT KNOWN. THE DURATION OF CLINICAL USE WAS NOT PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6785336 ↗
• MalfunctionJul 21, 2017Split; Split

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE CUSTOMER STATES THAT THE "CATHETER DISSECTED BETWEEN 13 AND 15 CM AND CUT TO THE 17 CM. PROBLEM SEEN WITH THE REMOVAL OF THE CATHETER." THERE ARE NO REPORTED AVERSE PATIENT CONSEQUENCES. THE CUSTOMER ADVISED THAT NO SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731748 ↗
• MalfunctionJun 6, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC WAS IMPLANTED FOR TREATMENT OF A PRE-EXISTING (B)(6) INFECTION WITH RESULTANT FEVER. THE DEVICE RECIPIENT IS A POST-ACUTE CARE AND REHABILITATION PATIENT. A LEAK WAS IDENTIFIED AT THE VALVE LEVEL (PURPLE COLOUR) AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE LEAK WAS OBSERVED WHILE ATTEMPTING TO ADMINISTER ANY LIQUID. THE DEVICE WAS EXPLANTED; IT IS NOT KNOWN IF THE EXPLANT WAS AT THE END OF DEVICE USE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. FOLLOW-UP TO THE CUSTOMER WAS CONDUCTED REQUESTING THE DATE OF DEVICE IMPLANT AND IF THE PATIENT WAS CULTURE POSITIVE FOR THE REPORTED S. EPIDERMITIS INFECTION PRIOR TO THE IMPLANT. THE PATIENT WAS TREATED WITH VANCOMYCIN FOR 10 DAYS WITH THE SAME PICC LINE. THE CUSTOMER RESPONDED INDICATING NO ONE IS ABLE TO PROVIDE ANY INFORMATION. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614771 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE ON (B)(6) 2016 ON THE LEFT (DOMINANT) HAND. A LARGE HEMATOMA MEASURING 25 X 40 MM WAS OBSERVED TWO WEEKS LATER ON (B)(6) 2016. THE PATIENT UNDERWENT SURGICAL DRAINAGE OF THE HEMATOMA ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; No Code Available

  MAUDE report 6300051 ↗
• InjuryOct 25, 2016Material Disintegration; Material Disintegration

  IT WAS REPORTED DURING A PICC LINE PLACEMENT UNDER ECHO-GRAPHIC CONTROL WHEN THE ANESTHETIST INSERTED THE WIRE GUIDE IN THE VEIN HEADING TO THE ATRIUM, THROUGH THE NEEDLE, THE GUIDE DISINTEGRATED. UNDER FLUOROSCOPIC CONTROL, THE ANESTHETIST SAW THE WIRE GUIDE HAD LOST ITS SHAPE, REPORTEDLY IT WAS THINNER. AFTER REMOVAL OF THE WIRE GUIDE, THE ANESTHETIST COMPLETED THE PROCEDURE WITH A TWO LUMEN PICC LINE USING THE GUIDE AND THE NEEDLE AND COMPLETED THE PROCEDURE. AN UNKNOWN AMOUNT OF ADDITIONAL TIME WAS ADDED TO THE PROCEDURE DUE TO THE EVENT. 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 6055277 ↗