Turbo-Ject G56199Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002561991), received between Dec 21, 2016 and Apr 15, 2019 — classified as 12 injuries, 5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2019Fracture; Fracture

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8515612 ↗
• MalfunctionSep 27, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY TRANSLATION OF THE ORIGINAL COMPLAINT DESCRIPTION DURING ADMINISTRATION TO THE PATIENT THE TIP OF THE TURBO-JECT POWER INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IS DEFECTIVE AT THE PURPLE ATTACHMENT. A REPLACEMENT PICC LINE WAS USED. THEY WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED. AT THE TIME OF THIS REPORT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7916075 ↗
• MalfunctionSep 22, 2017Leak/Splash

  THE PICC LINE APPEARS TO BE LEAKING AT THE HUB. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE WAS REMOVED, AND THERE WERE NO ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6888435 ↗
• MalfunctionSep 22, 2017Leak/Splash

  THE PICC LINE APPEARS TO BE LEAKING AT THE HUB. 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 6888062 ↗
• InjurySep 21, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED IN AN ANSM REPORT RECEIVED ON (B)(6) 2019, THE PICC LINE WAS INSERTED ON (B)(6) 2017. THE DIFFICULTY EXPERIENCED DURING CATHETERIZATION WAS DUE TO THE DEVICE TWISTING, STOPPING THE WIRE FROM MOVING FORWARD. THE PATIENT'S RIGHT ARM COULD NOT BE USED DUE TO A PREVIOUS LYMPH NODE DISSECTION. THE PICC LINE HAD BEEN CUT TO 20CM. ON (B)(6) 2017, UPON INJECTING A MIXTURE OF KETAMINE, MORPHINE AND MIDAZOLAM, A SUB-CUTANEOUS DIFFUSION OF THE PRODUCT INJECTED INTO THE PICC WAS NOTICED. A LEAK IN THE CATHETER WAS THEN SUSPECTED, AND THE CATHETER WAS THEN REMOVED. IT WAS DETERMINED THAT THE IMPLANTABLE VENOUS ACCESS DEVICE WOULD BE OPERATIONAL AGAIN AFTER THE ABLATION OF A SUB-CUTANEOUS METASTASIS THAT WAS PREVENTING THE DEVICE'S MOBILITY. THE OUTCOMES OF THE PATIENT INCLUDED A REGRESSIVE SPONTANEOUS EXTRAVASATION WITHOUT A LESION AND PICC CATHETER ABLATION. THE HEALTHCARE FACILITY SENT TO A REPORT TO THE MANUFACTURER AND PROVIDED THE DEVICE FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 6882055 ↗
• MalfunctionSep 19, 2017Difficult to Advance

  THE INTRODUCER SHEATH WOULD NOT ADVANCE SMOOTHLY, ON CLOSE INSPECTION THERE WAS A BUCKLED ON THE EDGE OF THE OUTER GREY TUBING, APPROX. 1.5CM PROXIMAL TO TIP. THERE WAS BURRING ON THE INTRODUCER SHEATH. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS REPEATED WITH A NEW KIT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877105 ↗
• MalfunctionSep 19, 2017Partial Blockage; Device Inoperable; No Flow

  IT WAS REPORTED THE PICC LINE (BRACHIAL PLACEMENT) WAS CUT ON THE PROXIMAL PART. THE PATIENT SHOWED THE USER FACILITY THAT THE PICC LINE CATHETER DIVIDED SPONTANEOUSLY RENDERING IT UNUSABLE. AS A RESULT, THE PICC LINE WAS REMOVED. IT WAS ALSO NOTED THAT NO LIQUID WAS PASSING THROUGH AS THE CATHETER WAS BLOCKED AT THE "VERY TOP".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875346 ↗
• InjurySep 19, 2017Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANTATION, THE PICC LINE WAS FOUND TO BE LEAKING WHILE IT WAS BEING FLUSHED WITH SALINE. ON CLOSE INSPECTION, THE USER FOUND A SLIGHT SEPARATION BETWEEN THE CLEAR TUBING AND THE PURPLE HUB. THE PICC WAS REMOVED AND REPLACED. NO PARTS OF THE COMPLAINT DEVICE WERE LEFT IN THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6875206 ↗
• InjurySep 18, 2017Fluid/Blood Leak; Material Separation

  THE DEVICE WAS INSERTED INTO THE PATIENT FOR ANTIBIOTICS IN THE HOSPITAL. WHEN NURSE ATTEMPTED TO REPLACE THE NEXT DOSE, THE PICC LEAKED WHEN FLUSHED WITH SALINE. ON CLOSE INSPECTION, THERE WAS A SLIGHT SEPARATION BETWEEN THE CLEAR TUBING AND HE PURPLE HUB. PICC REMOVED AND REPLACED. NO OTHER ADVERSE EFFECT TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6873801 ↗
• InjurySep 18, 2017Leak/Splash; Split

  THE DEVICE WAS INSERTED SO THAT THE PATIENT COULD RECEIVE ANTIBIOTICS IN THE HOSPITAL. WHEN NURSE ATTEMPTED TO REPLACE NEXT DOSE, THE PICC LEAKED WHEN FLUSHED WITH SALINE. ON CLOSE INSPECTION, THERE WAS A SLIGHT SEPARATION BETWEEN THE CLEAR TUBING AND HE PURPLE HUB. PICC REMOVED AND REPLACED. NO ADDITIONAL ADVERSE EFFECT TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6873396 ↗
• InjuryJul 19, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT POWER INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. A HEMATOMA DEVELOPED WHEN THE TECHNOLOGIST ATTEMPTED TO PLACE THE NEEDLE INTO THE PATIENT'S VEIN. THE TECHNOLOGIST THEN ATTEMPTED TO PLACE THE GUIDE WIRE THROUGH THE NEEDLE AT THE SITE OF THE HEMATOMA. THE WIRE WAS NOT ABLE TO PASS TO THE VEIN BUT RATHER BECAME INVOLVED WITHIN THE HEMATOMA. THE TECHNOLOGIST MANIPULATED THE NEEDLE AND GUIDE WIRE AND ATTEMPTED TO FORCE THE GUIDE WIRE TO THE VEIN. THE TECHNOLOGIST THEN ATTEMPTED TO REMOVE THE GUIDE WIRE BACK THROUGH THE NEEDLE. A PART OF A PICC LINE STAYED IN THE ARM OF THE PATIENT. A RADIOLOGIST WAS CALLED TO ASSIST IN THE REMOVAL OF THE NEEDLE. IT IS NOT KNOWN IF ANY SECTION OF THE GUIDE WIRE IS RETAINED. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE MANIPULATION OF THE WIRE CAUSED IT TO UNRAVEL. ADDITIONALLY, THE FRAGMENT THAT REMAINED IN THE VEIN WAS "ABOUT 1 CM". ANOTHER PICC LINE WAS INTRODUCED IN THE OPPOSITE ARM FOLLOWING THE EVENT AND THE PATIENT IS REPORTEDLY "OK".

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6725171 ↗
• InjuryJun 22, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT POWER INJECTABLE FOR AN UNSPECIFIED INDICATION. THE DISTAL PORTION OF THE WIRE GUIDE BECAME "STUCK IN THE SOFT PARTS." THE CLINICIAN WAS UNABLE TO RETRIEVE THE DEVICE. THE DEVICE UNRAVELED AND A 1CM SECTION OF THE DISTAL PORTION OF THE WIRE BROKE, A RADIOGRAPH CONFIRMED A RETAINED FRAGMENT IN "THE SOFT PARTS." AN ATTEMPT TO RETRIEVE THE FRAGMENT VIA A SKIN INCISION AND CUT-DOWN WAS NOT SUCCESSFUL. THE FRAGMENT REMAINS WITHIN THE PATIENT. THE IMPLANT PROCEDURE WAS THEN PERFORMED SUCCESSFULLY USING A CONTRALATERAL ARM. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED; ADDITIONAL INFORMATION WAS REQUESTED. IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6659837 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT POWER INJECTABLE CATHETER FOR AN UNSPECIFIED INDICATION. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE SHEATH WITHIN THE PATIENT'S LEFT BASILIC VEIN DURING PLACEMENT. THE WIRE AND SHEATH WERE EXCHANGED WITH A COMPETITORS PRODUCT. THERE IS NO REPORT OF ANY DEVICE MALFUNCTION. THE CUSTOMER STATED THAT THE PATIENT LOST APPROXIMATELY 100CC OF BLOOD DURING THE DEVICE EXCHANGE. 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: Blood Loss

  MAUDE report 6584246 ↗
• InjuryApr 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS IMPLANTED ON (B)(6) 2017 FOR ANTIBIOTIC THERAPY. THE HUB REPORTEDLY DISCONNECTED FROM THE CATHETER AFTER TREATMENT ON (B)(6) 2017. THE CONDITIONS AND HANDLING CIRCUMSTANCES AT THE TIME OF THE EVENT ARE NOT KNOWN. THE DEVICE WAS EXPLANTED; IT IS NOT KNOWN IF A REPLACEMENT DEVICE WAS EXCHANGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; NO DEVICE WAS RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6463209 ↗
• InjuryJan 4, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) IN PLACE FOR APPROXIMATELY 3 MONTHS WAS LEAKING BETWEEN THE HUB AND THE CATHETER LINE OUTSIDE OF THE PATIENT¿S ANATOMY. A NEW PICC LINE WAS INSERTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 6223498 ↗
• InjuryDec 23, 2016Leak/Splash; Leak/Splash

  A PICC WAS PLACED IN THE PATIENT ON THE (B)(6) OF (B)(6) 2016. IT WAS USED EVERY DAY WITHOUT ANY ISSUE. ON THE (B)(6) OF (B)(6) 2016, A LEAK OF PHYSIOLOGICAL SERUM WITH BLOOD OCCURRED AT THE PROXIMAL END OF THE PICC. THE PATIENT HAD THE SHIVERS. THE DOCTOR ADVISED THAT THE PICC LINE HAD A CUT AT THE JUNCTION BETWEEN THE EXTENDER AND THE LUER LOCK FEMALE CONNECTION. A PERIPHERIC VENOUS TRANSFUSION WAS DONE IMMEDIATELY. ON THE (B)(6) OF (B)(6) 2016, THEY TOOK THE FAULTY PICC OUT OF THE PATIENT AND REPLACED IT WITH A NEW ONE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6202472 ↗
• InjuryDec 21, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IMPLANTED ON (B)(6) 2016. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2016 WITH A LEAKING PICC LINE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A SURGICAL PROCEDURE PERFORMED TO REMOVE AND REPLACE THE LEAKING PICC LINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Code Available

  MAUDE report 6192666 ↗