Cook Spectrum Turbo-Ject G05676Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002056763), received between Feb 6, 2017 and May 13, 2022 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC SEPARATED AND/OR LEAKED ON 27JAN2022. THE DEVICE WAS REMOVED AND REPLACED. THE ISSUE ALSO RESULTED IN A NEED FOR INCREASED MONITORING. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401963 ↗
• MalfunctionMay 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC SEPARATED AND/OR LEAKED ON (B)(6) 2021. IT WAS UNKNOWN IF THE DEVICE WAS REPLACED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401818 ↗
• InjuryMay 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC SEPARATED AND/OR LEAKED ON (B)(6) 2022. THE DEVICE WAS REMOVED AND REPLACED. THE INCIDENT RESULTED IN INITIAL OR PROLONGED HOSPITALIZATION AND CAUSED TEMPORARY HARM. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401641 ↗
• InjuryMay 13, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC SEPARATED AND/OR LEAKED ON (B)(6) 2022. THE DEVICE WAS REMOVED AND REPLACED. THE ISSUE ALSO RESULTED IN A NEED FOR INCREASED MONITORING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401096 ↗
• InjuryMay 5, 2022Fluid/Blood Leak; Leak/Splash; Material Separation; Detachment of Device or Device Component; Fluid/Blood Leak; Leak/Splash; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC BROKE AND LEAKED. THE DEVICE WAS PLACED (B)(6) 2022. TEN DAYS LATER, THE PATIENT'S PICC LINE WAS NOT FLUSHING AND WAS LEAKING. THE PATIENT RETURNED TO THE CLINIC AND IT WAS DETERMINED THE LINE WAS "BROKEN JUST BEYOND THE CLAVE." THE DEVICE WAS REMOVED AND REPLACED. NO CULTURES WERE DRAWN. NO OTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292051 ↗
• MalfunctionApr 19, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THERE WAS A CRACK IN THE TUBING OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC AFTER PLACEMENT. THE DEVICE WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, BLOOD LEAKED THROUGH A SMALL CRACK IN THE TUBING WHILE DRAWING BLOOD CULTURES OUT OF THE RIGHT ARM. THE DEVICE WAS REMOVED AND NO INFECTION WAS PRESENT. IT WAS DETERMINED ANOTHER DEVICE WAS NOT REQUIRED AS THE PATIENT HAD A DOUBLE-PORT PLACED PRIOR TO THIS DISCOVERY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141000 ↗
• InjuryApr 15, 2022Crack; Fluid/Blood Leak; Material Separation; Crack; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THREE SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC DEVICES CRACKED AT THE HUB. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL, OUTPATIENT PROCEDURE TO REPLACE WITH DEVICE WITH A COMPETITOR'S PRODUCT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118241 ↗
• MalfunctionFeb 23, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC IMPLANTED IN A (B)(6) FEMALE PATIENT FOR THE IV ADMINISTRATION OF FLUIDS AND MEDICATIONS, WAS FOUND TO BE LEAKING BOTH FLUID AND BLOOD. THE MOTHER OF THE PATIENT PRESSED THE CALL LIGHT AND REPORTED THAT THE PATIENT'S LINE WAS LEAKING. UPON ENTERING THE ROOM, THE NURSE DISCOVERED MAINTENANCE IV FLUID DRIPPING FROM THE PICC LINE. THE TUBING AND CONNECTIONS WERE FOUND TO BE SECURED, YET FLUID WAS LEAKING AS THE INFUSION CONTINUED. APPROXIMATELY 5ML OF FLUID WAS NOTED ON THE FLOOR. THE NURSE THEN DELAYED THE PUMP, DETACHED THE TUBING FROM THE PATIENT AND CAPPED THE INFUSING IV LINE IN ORDER TO IDENTIFY THE LOCATION OF THE FLUID LEAK. AS SOON AS THE NURSE DETACHED THE CURRENT INFUSION, A SMALL AMOUNT OF BLOOD BEGAN LEAKING OUT OF THE LINE. THE NURSE THEN GRABBED ATRAUMATIC CLAMPS FROM A DRAWER AND CLAMPED ONE IN THE MIDDLE OF THE CLAVE AND ANOTHER WHERE THE LINE WAS SUTURED IN. AS BLOOD LEAKAGE CONTINUED SLOWLY, THE NURSE REMOVED THE CLAMP BELOW THE BOTTOM OF THE DRESSING. THIS CAUSED THE LEAKAGE TO STOP. A SMALL HOLE WAS NOTED 5CM ABOVE THE CLAVE. THE CHARGE NURSE WAS CALLED TO LOOK AT THE LINE AND LATER DISCUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588610 ↗
• InjuryAug 4, 2021Fracture; Material Separation; Fracture; Material Separation

  IN ADDITIONAL INFORMATION RECEIVED ON 20AUG2021, IT WAS CONFIRMED THAT THE DEVICE BROKE AND THEN WAS REMOVED AND REPLACED, ALL ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274091 ↗
• InjuryJun 7, 2021Break; Break

  IT WAS REPORTED THAT A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC BROKE. THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT VEIN AND WAS USED FOR INFUSION OF MAGNESIUM SULFATE. THE DEVICE WAS HEPARIN LOCKED. AS A RESULT OF THE BREAK, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 3FR SPECTRUM IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11951926 ↗
• MalfunctionJun 1, 2020Crack; Fluid/Blood Leak; Material Separation; Crack; Fluid/Blood Leak; Material Separation

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10105338 ↗
• InjuryFeb 27, 2020Crack; Crack

  IT WAS REPORTED THAT A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC WAS FOUND TO BE LEAKING FROM A CRACK IN THE TUBING. THE PICC LINE WAS INSERTED INTO THE PATIENT'S RIGHT BASILIC VEIN ON (B)(6) 2018 UNDER GENERAL ANESTHESIA. IT WAS FIRST REPORTED THAT THE PICC WAS LEAKING ON (B)(6) 2018. THE LINE WAS FOUND TO BE CRACKED AT THE "DISTAL END OF THE CLEAR TUBING JUST PRIOR TO THE ORANGE HUB". THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO HAVE THE PICC "REWIRED". ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT AND EVENT DETAILS. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED REGARDING THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9763371 ↗
• InjuryApr 2, 2019Fracture; Fracture

  IT WAS REPORTED A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC WAS USED IN AN UNKNOWN PATIENT DURING AN UNKNOWN PROCEDURE. AS REPORTED BY THE USER THE DEVICE " FRACTURED AT THE DISTAL END AT THE JUNCTION OF THE ORANGE CONNECTOR AND THE CLEAR TUBING." NO PORTION OF THE DEVICE REMAINS IN PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THERE ARE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THE DEVICE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472731 ↗
• InjuryMar 6, 2019Fracture; Leak/Splash; Fracture; Leak/Splash

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8394272 ↗
• InjuryJun 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC LINE HAD FRACTURED AND BEGAN LEAKING LESS THAN SIXTY DAYS AFTER PLACEMENT. THE PATIENT REQUIRED A GENERAL ANESTHETIC TO REPLACE THE LINE. THE PATIENT IS CURRENTLY AT HOME ON ANTIBIOTICS. TO DATE, ADDITIONAL INFORMATION WITH REGARDS TO THE PATIENT, DEVICE AND EVENT ARE UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 7649665 ↗
• MalfunctionMar 14, 2018Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT, DURING A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE PLACEMENT PROCEDURE, THE INSERTED WIRE COULD NOT BE REMOVED FROM THE LINE. THE WIRE WAS INSERTED TO ESTABLISH ACCESS, BUT ONCE THE LINE WAS CENTRAL, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE GUIDE WIRE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE GUIDE WIRE AND PICC LINE TOGETHER AS A UNIT TO THE SUBCLAVIAN, AND THEN REMOVE THE WIRE. A DIFFERENT WIRE WAS USED TO COMPLETE THE PROCEDURE, WITH NO FURTHER ISSUES REPORTED. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE PRODUCT ISSUE, AND NO PATIENT ADVERSE EVENTS WERE REPORTED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337689 ↗
• InjuryFeb 13, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) BROKE AT THE DISTAL END OF THE DEVICE, JUST PRIOR TO THE ORANGE END. THE PRODUCT PROBLEM NECESSITATED THE REWIRING OF THE LINE UNDER LOCAL ANESTHESIA IN THE INTERVENTIONAL SUITE. THE DEVICE HAD BEEN PLACED ON (B)(6) 2017, AND THE ISSUE WAS DISCOVERED ON (B)(6) 2017. ADDITIONAL INFORMATION WAS LATER RECEIVED FROM THE CUSTOMER UPON REQUEST. THE BREAK WAS DESCRIBED AS A PARTIAL SEPARATION OF THE ORANGE HUB. THE CATHETER WAS OPERATIONAL FOR 70 DAYS PRIOR TO THE DISCOVERY OF THE FAILURE, AND THE ISSUE WAS REPORTEDLY NOT WITH THE HUB ITSELF, BUT RATHER THE TUBING THAT ENTERS THE HUB PORTION OF THE DEVICE. THE COMPLAINT PRODUCT WAS PRIMARILY USED FOR TOTAL PARENTERAL NUTRITION INFUSION ADMINISTERED ON A DAILY BASIS.THE DEVICE HAS BEEN RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, INVESTIGATION AND EVALUATION ARE IN PROGRESS.

  Patient problems: No Code Available

  MAUDE report 7268618 ↗
• InjuryJul 1, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC ON (B)(6) 2017. THE PICC LINE BROKE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT CATHETER EXPLANT AND REPLACEMENT WITH A BROVIAC CATHETER UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED. 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 6683458 ↗
• InjuryJun 26, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE PICC LINE WAS OBSERVED BROKEN AND LEAKING ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE. THERE IS NO INDICATION THAT A REPLACEMENT DEVICE WAS IMPLANTED. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER SERVICE FOR TRANSITION TO AN IVAD (IMPLANTABLE VENTRICULAR ASSIST DEVICE.) THE CUSTOMER REPORTS THE EVENT CAUSED INCONVENIENCE. 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 6666894 ↗
• InjuryJun 23, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) FOR AN UNSPECIFIED INDICATION ON (B)(6) 2017. THE CUSTOMER REPORTED THAT THE CLINICAL UNIT NOTICED THE PICC LINE CRACKED AND LEAKING ON (B)(6) 2017. THE HANDLING CONDITIONS AND CIRCUMSTANCES LEADING TO THE EVENT ARE NOT KNOWN. THE CATHETER WAS EXPLANTED AND REPLACED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA ON (B)(6) 2017. NO FURTHER EVENT OF PATIENT DETAILS WERE PROVIDED. THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6663798 ↗
• MalfunctionFeb 6, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IMPLANTED ON (B)(6) 2016. THE PICC LINE IS USED FOR A PATIENT'S ONCOLOGY TREATMENT. THE PICC LINE BROKE AT THE JUNCTION OF THE HUB AND THE CATHETER NINE (9) DAYS FOLLOWING IMPLANT. THE PICC LINE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6303288 ↗
• InjuryFeb 6, 2017Occlusion Within Device; Occlusion Within Device

  INTERNATIONAL CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS IMPLANTED ON (B)(6) 2016 FOR ONCOLOGY TREATMENT. THE PICC LINE BECAME OCCLUDED AND WAS REMOVED AND REPLACED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 6303283 ↗