Cook Spectrum Turbo-Ject G34545Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002345454), received between Nov 14, 2016 and Nov 12, 2021 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Crack; Fracture; Crack; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 12807194 ↗
• InjuryJun 30, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION REGARDING EVENT DETAILS WAS RECEIVED ON 30SEP2020. THE DEVICE WAS BEING PLACED IN THE PATIENT'S RIGHT BRACHIAL VEIN. IT WAS REPORTED THAT THE WIRE GUIDE "APPEARED STUCK AND THERE WAS DIFFICULTY MANEUVERING AND PULLING THE GUIDE WIRE BACK THROUGH THE PEEL AWAY". THE PATIENT UNDERWENT ADDITIONAL HOSPITALIZATION AND REQUIRED A SURGICAL INTERVENTION DUE TO THIS OCCURRENCE. IT WAS REPORTED THAT THE PATIENT HAD TO BE TRANSFERRED TO "AN OUTSIDE HIGHER LEVEL INSTITUTION" FOR AN IR PROCEDURE TO RETRIEVE THE GUIDEWIRE FRAGMENT. THE SEPARATED PORTION OF THE GUIDE WAS SUCCESSFULLY "REMOVED AS A WHOLE" THROUGH THE NEEDLE AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10214958 ↗
• InjuryAug 20, 2019Break; Break

  ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION WAS RECEIVED ON 28AUG2019. IT WAS REPORTED THAT DURING A PICC LINE INSERTION IN A VEIN IN THE ARM ON (B)(6) 2019, THE PICC LINE CRACKED AND BROKE BELOW THE HUB WHICH RESULTED IN OOZING. THE DEVICE HAD TO BE REMOVED IMMEDIATELY ON (B)(6) 2019 AND REPLACED WITH A NEW ONE. NO SECTION OF THE DEVICE WAS LEFT REMAINING INSIDE THE PATIENT'S BODY. ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE AND THE DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Information

  MAUDE report 8911024 ↗
• MalfunctionJul 3, 2018Split; Split

  IT WAS REPORTED A SPECTRUM TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC CATHETER WAS FOUND TO BE SPLIT DURING ITS SCHEDULED REMOVAL. VISUAL INSPECTION PERFORMED BY THE MEDICAL PERSONNEL STATED THE DEVICE WAS SPLIT OPEN APPROXIMATELY 3CM. THE PATIENT COMPLETED TREATMENT OVER THE COURSE OF AN UNKNOWN AMOUNT OF TIME WITH THE LINE PLACED IN ARM. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE AN ADDITIONAL LINE INSERTION DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660409 ↗
• InjuryDec 18, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) BROKE RIGHT BELOW THE ORANGE HUB OF THE DEVICE, AT THE CONNECTION BETWEEN THE ORANGE HUB AND THE CLEAR LINE. THE PICC WAS PLACED ON (B)(6) 2017 AND THE BREAK WAS DISCOVERED BY THE PATIENT CONTACT ON (B)(6) 2017. THE BREAK WAS DESCRIBED TO BE AN INCOMPLETE BREAK, AS THE ORANGE HUB ITSELF WAS STILL INTACT. THE PATIENT CONTACT COVERED THE AREA WITH TEGADERM, AND WAS INSTRUCTED TO BRING THE PATIENT IN FOR EXAMINATION. THE PATIENT WAS ADMITTED FOR LINE REPLACEMENT. THE PATIENT WAS RECEIVING INFUSIONS OF CASPOFUNGIN AND AMBISOME. A DEVICE WAS RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7126301 ↗
• InjurySep 19, 2017Material Rupture

  A PATIENT HAD THE PICC LINE 2 MONTHS PRIOR. IT WAS STATED TO THE FACILITY THAT WHEN THE MEDICATION WAS INJECTED, IT COULD BE FELT GOING IN. THE PICC LINE WAS REMOVED AND REPLACED. UPON LOOKING AT THE PICC LINE, IT HAD RUPTURED. THE PATIENT HAD ETHANOL LOCK EACH DAY FOR FOUR HOURS OVER THE PREVIOUS 2 MONTHS. THE USE OF THE ETHANOL WAS DISCONTINUED BECAUSE OF THE BELIEF THAT THE ETHANOL COULD HAVE POTENTIALLY BEEN ALLOWING CLOT OCCLUSION. SUBSEQUENTLY, HEPARIN LOCK WAS USED. THE CATHETER WAS PLACED IN FEMORAL LOCATION. THE RUPTURE SITE WOULD CORRESPOND TO A LEVEL IN THE ILIAC VEIN NEAR BIFURCATION. THE TIP WAS CUT OFF FOR CULTURE PURPOSES. ASIDE FROM THE ADDITIONAL PROCEDURE TO REPLACE THE DEVICE, THERE WERE NO OTHER REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6876014 ↗
• InjurySep 15, 2017Leak/Splash; Split

  THE CUSTOMER REPORTED THAT 65 DAYS AFTER IMPLANTATION, THE PICC LINE BEGAN LEAKING DUE TO A SPLIT IN THE CLEAR PLASTIC JUST BELOW THE HUB. THE PICC WAS REPLACED WITH ANOTHER DEVICE. NO PART OF THE ORIGINAL DEVICE REMAINED IN THE PATIENT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6869000 ↗
• InjurySep 6, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT RECEIVED A SPECTRUM TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC FOR UNSPECIFIED TREATMENT. THE PICC LINE BROKE ON THE EXTENSION TUBING BENEATH THE WHITE END CAP HUB. THE DEVICE WAS EXPLANTED AND REPLACED. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING 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.

  Patient problems: No Code Available

  MAUDE report 6846416 ↗
• InjuryJul 18, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT RECEIVED A SPECTRUM TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC ON (B)(6) 2017 FOR UNSPECIFIED TREATMENT. THE PICC LINE BROKE ON THE EXTENSION TUBING BENEATH THE WHITE END CAP HUB DURING DEVICE MAINTENANCE ON (B)(6) 2017. THE DEVICE WAS EXPLANTED AND REPLACED. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING 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.

  Patient problems: No Code Available

  MAUDE report 6720789 ↗
• InjuryJun 15, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT HAD A SPECTRUM TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE PICC LINE REPORTEDLY BROKE ON (B)(6) 2017. THE BREAK WAS OBSERVED ON ONE OF THE EXTENSION LUMENS INDICATED TO BE THE WHITE LUMEN THAT IS NOT POWER INJECTABLE. CUSTOMER STATES THAT THE DEVICE BROKE RIGHT UNDER THE BOTTOM OF THE PLASTIC PART WITH THE INFORMATION ON IT. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED. NO FURTHER PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6643291 ↗
• MalfunctionNov 14, 2016Leak/Splash; Leak/Splash

  A PICC PROCEDURE WAS PERFORMED ON THE (B)(6) MALE PATIENT AND IT WAS REPORTED THAT TWO MONTHS AFTER PLACEMENT, THE WHITE LUMEN WAS LEAKING. A NEW PICC WAS PLACED AND DUE TO THE PATIENT'S SLUGGISH BLOOD RETURN AND DIFFICULTY IN FLUSHING, THE USER ADMINISTERED TPA IN THE WHITE PORT JUST AFTER ONE WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 6100170 ↗