Turbo-Ject G34514Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002345140), received between Sep 12, 2016 and Dec 4, 2018 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2018Crack; Crack

  IT WAS REPORTED SEVEN (7) DAYS AFTER A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LINE WAS PLACED, THE WHITE HUB WAS FOUND CRACKED WHERE THE HUB AND CATHETER MEET. A SMARTSITE NEEDLE FREE VALVE WAS CONNECTED TO THE LUMEN AND NO INSTRUMENT WAS USED TO TIGHTEN/RELEASE THE FITTING. 70% ALCOHOL SWAB WAS USED TO SCRUB THE HUB AND ALLOWED TO DRY COMPLETELY BEFORE A NEW NEEDLESS CONNECTOR PLACED. THE LINE WAS CLAMPED AND ANOTHER LUMEN WAS USED AS INTENDED. AS REPORTED, THE DEVICE WAS FOUND CRACKED WHILE THE PATIENT WAS RECEIVING THE LAST ROUND OF CHEMOTHERAPY, THEREFORE, THE DEVICE WAS NOT REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8131186 ↗
• InjuryOct 15, 2018Crack; Crack

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC PLACED ON (B)(6) 2018 IN A PATIENT'S ARM WAS FOUND TO HAVE BLOOD BACKING UP IN THE TUBING. IT WAS ALSO NOTED TPN WAS LEAKING FROM THE PURPLE HUB WHICH WAS OBSERVED TO BE CRACKED. THE LINE WAS REWIRED WITH A LIKE DEVICE UTILIZING THE SAME INSERTION SITE. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY STATED THAT IF NEEDLELESS CONNECTORS BECOME TOO TIGHT, FORCEPS ARE USED OVER GAUZE TO DISCONNECT THE PAIR. THE DEVICE WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR INVESTIGATION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7965052 ↗
• InjuryOct 8, 2018Crack; Crack

  A SUS VOLUNTARY REPORT, MW5080167, WAS RECEIVED ON 25OCT2018 AND RECONCILED WITH THIS CASE.

  Patient problems: No Code Available

  MAUDE report 7944628 ↗
• InjuryOct 3, 2018Crack; Crack

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC WAS PLACED FOR TREATMENT ON (B)(6) 2018. THE WHITE HUB WAS FOUND CRACKED ON (B)(6) 2018 AND THE LINE WAS CLAMPED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, HOWEVER, THE CUSTOMER STATES THEY ARE AT A HIGHER RISK FOR INFECTION. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE IN THE OR TO PLACE A TUNNELED BARD CATHETER.

  Patient problems: No Code Available

  MAUDE report 7931807 ↗
• InjuryOct 2, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC WAS PLACED ON (B)(6) 2018 IN THE LEFT ANTECUBITAL REGION SECURED BY SUTURES, CENTURION SORBAVIEW SHIELD AND AN ARM IMMOBILIZER. ON (B)(6) 2018, BOTH THE PURPLE AND WHITE LUMENS WERE FOUND LEAKING WHERE THE CATHETER MEETS THE HUB. A NEEDLELESS CONNECTOR WAS USED FOR SINGLE AND CONTINUOUS INFUSIONS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, HOWEVER, AN ADDITIONAL PROCEDURE WAS REQUIRED TO REPLACE THE LINE.

  Patient problems: No Code Available

  MAUDE report 7925546 ↗
• InjuryOct 1, 2018Crack; Crack

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC HUB WAS FOUND CRACKED WHERE THE LINE EXTENSION TUBING MEETS THE HUB. ADDITIONAL PATIENT AND EVENT INFORMATION HAVE BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7923022 ↗
• InjurySep 17, 2018Material Separation; Material Separation

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC BROKE WHERE THE WHITE HUB AND CATHETER MEET. THIS CATHETER WAS PLACED ON (B)(6) 2018 AND REMAINED IN SITU AND CLAMPED UNTIL IT WAS REPLACED ON (B)(6) 2018. THE USER FACILITY REPORTED THIS EVENT ON A 3500A FORM ON (B)(6) 2018. THE REPORTED COMPLAINT DEVICE WAS THE REPLACEMENT CATHETER USED AFTER THE INITIAL DEVICE PRESENTED A SIMILAR FAILURE REPORTED ON MEDWATCH 1820334-2018-02595. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7881565 ↗
• InjuryAug 30, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN INTERVENTIONAL RADIOLOGIST PLACED A TURBO-JECT DOUBLE LUMEN POWER- INJECTABLE PICC INTO THE LEFT BRACHIAL VEIN ON (B)(6) 2018. THE LINE WAS USED TO DELIVER ONE TIME AND CONTINUOUS MEDICATIONS. THIRTEEN DAYS AFTER PLACEMENT, (B)(6) 2018, THE DEVICE WAS FOUND TO BE LEAKING AT THE PURPLE AND WHITE HUBS. THE DEVICE WAS REMOVED AND ANOTHER LINE WAS PLACED IN THE RIGHT ARM WITH NO INCIDENT. BOTH DEVICES WERE SUTURED IN PLACE, SECURED WITH DRESSING AND WRAPPED WITH AN ELBOW/WRIST IMMOBILIZER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7834345 ↗
• InjuryJul 13, 2018Crack; Crack

  IT WAS REPORTED A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE CRACKED AT THE CONNECTION OF THE HUB AND CATHETER. THIS INCIDENT WAS MITIGATED WITH A PICC REWIRE. THE LINE WAS IN PLACE FOR A TOTAL OF 4 DAYS, SECURED WITH A STATLOCK, AND USED TO DELIVER THE FOLLOWING: CHEMO, LORAZEPAN, MYCOPHENOLATE AND DIPHENHYDRAMINE. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAVE NOT BEEN MADE AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 7686198 ↗
• InjuryJul 11, 2018Break; Break

  IT WAS REPORTED THE THE HUB BROKE WHERE THE CATHETER AND WHITE HUB MEET ON A 4FR TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) REQUIRING ANOTHER PICC LINE TO BE PLACED. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 7680498 ↗
• InjuryJan 9, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, 77 DAYS FOLLOWING IMPLANTATION, THE TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE BEGAN LEAKING FROM THE WHITE HUB AREA OF THE DEVICE. THE PRODUCT PROBLEM ULTIMATELY NECESSITATED THE EXCHANGING OF THE LINE. NO FURTHER COMPLICATIONS OR WERE REPORTED. THE CUSTOMER ALSO REPORTED DEVICE WAS BEING FLUSHED WITH SALINE AND THEN 1 ML HEPARIN LOCKED (10 UNITS/ML) TWICE A DAY . IN ADDITION, 1 ML OF 70 PERCENT ETHANOL WAS PLACED TO DWELL FOR FOUR HOURS EVERY SATURDAY, A TOTAL OF 12 ETHANOL LOCKS SINCE (B)(6) 2017 HAD BEEN PERFORMED. THE PICC LINE WAS BEING UTILIZED FOR INTERMITTENT MEDICATIONS: BUMETANIDE, ATIVAN (LORAZAPAM), CHLORATHIAZIDE AND POTASSIUM CHLORIDE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7177059 ↗
• InjuryMar 31, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LINE WAS IMPLANTED ON (B)(6) 2017 FOR TREATMENT OF LEUKEMIA. THE HUB CRACKED / SEPARATED FROM THE CLEAR EXTENSION TUBE ON OR ABOUT (B)(6) 2017. THE CONDITIONS AND CIRCUMSTANCES SURROUNDING THE DEVICE USE AND HANDLING AT THE TIME OF THE EVENT ARE NOT KNOWN. THE PATIENT WAS RETURNED TO THE HOSPITAL FOR COMPLETE REMOVAL OF THE DEVICE AND EXCHANGE WITH A NEW UNSPECIFIED CATHETER. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6450187 ↗
• InjuryMar 31, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS IMPLANTED ON AN UNSPECIFIED DATE FOR TREATMENT OF LEUKEMIA. THE HUB OF THE PICC LINE REPORTEDLY SEPARATED / CRACKED ON OR ABOUT (B)(6)2017. THE PATIENT WAS RETURNED TO THE HOSPITAL AND THE DEVICE WAS COMPLETELY EXPLANTED AND EXCHANGED WITH A NEW DEVICE. THE CONDITIONS AND HANDLING CIRCUMSTANCES OF THE DEVICE AT THE TIME OF THE EVENT ARE NOT KNOWN. THE DEVICE IS NOT AVAILABLE FOR EXAMINATION. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6450117 ↗
• InjuryFeb 14, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT HAD TWO PREVIOUSLY IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES CRACK AND LEAK AT THE JUNCTION OF THE HUB AND CATHETER WITHIN A TWO WEEK TIME FRAME. THE PICC LINE WAS IN CLINICAL USE FOR LESS THAN ONE WEEK PRIOR TO THIS EVENT. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW LINE. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6329466 ↗
• InjuryFeb 14, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT HAD TWO PREVIOUSLY IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES CRACK AND LEAK AT THE JUNCTION OF THE HUB AND CATHETER WITHIN A TWO WEEK TIME FRAME. THE PICC LINE WAS IN CLINICAL USE FOR LESS THAN ONE WEEK PRIOR TO THIS EVENT. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW LINE. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6329464 ↗
• InjuryFeb 6, 2017Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT A PREVIOUSLY IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS LEAKING AT THE HUB/CATHETER JUNCTION. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6304039 ↗
• MalfunctionOct 27, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PICC PLACEMENT PROCEDURE. THE PICC WAS PLACED IN THE LEFT FEMORAL IN EARLY (B)(6) 2016 AND WAS EXPLANTED IN LATE (B)(6) 2016. IN LATE SEPTEMBER THE DEVICE COMPLETELY SEPARATED AT THE PURPLE LUER AND THE EXTENSION TUBING. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6061792 ↗
• MalfunctionSep 12, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED AFTER A PICC REPLACEMENT PROCEDURE THAT A MALE PATIENT'S DEVICE WAS LEAKING AT THE HUB OF THE CATHETER JUNCTION. THE PATIENT HAD TO RETURN TO THE IR DEPARTMENT FOR A NEW PICC REWIRED. THE ORIGINAL DEVICE WAS SECURED WITH STATLOCK, TEGADERN, AND SURGICEL. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EVENTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5943754 ↗