Cook Spectrum Turbo-Ject G23914Recalls & reported problems
Cook Incorporated · Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant
All models of Cook Spectrum Turbo-Ject (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002239142), received between Oct 18, 2016 and Aug 24, 2021 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Crack1
- Fluid/Blood Leak1
- Fracture1
- Leak/Splash1
- Material Rupture1
- Material Separation1
Patient problems
- Pain2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Consequences Or Impact To Patient1
- Thrombus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2021Break; Fluid/Blood Leak; Fracture; Leak/Splash; Material Separation; Break; Fluid/Blood Leak; Fracture; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE WHITE LUMEN OF A RIGHT TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC WAS LEAKING. THE DEVICE WAS ASSESSED BY A VASCULAR ACCESS NURSE AND WAS DETERMINED TO BE LEAKING. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. UPON REMOVAL, THE DEVICE WAS NOTED TO BE BROKEN AT THE 20CM LEVEL. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12358397 ↗MalfunctionApr 29, 2020Crack; Crack
IT WAS REPORTED THAT A HUB OF A TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC CRACKED. THE CRACK WAS NOTICED AS CHEMOTHERAPY WAS BEING ADMINISTERED TO THE PATIENT. THE DEVICE WILL BE REPLACED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10009432 ↗InjuryJan 30, 2017Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED EVENT THAT THE TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER RUPTURED. AS REPORTED, A DILATOR WAS USED PRIOR TO CATHETER ADVANCEMENT. THE CATHETER WAS BEING PLACED IN THE RIGHT UPPER ARM AND THE CUSTOMER IS UNSURE AS TO WHETHER A SCALPEL WAS USED TO ENLARGE THE INSERTION SITE PRIOR TO INSERTION. ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT IMPACT. AS REPORTED, THE PATIENT EXPERIENCED PAIN IN UPPER ARM AND A NON-OCCLUSIVE DEEP VEIN THROMBOSIS (DVT).
Patient problems: No Code Available; Pain; Thrombus
MAUDE report 6287085 ↗InjuryOct 18, 2016Break; Break
INFORMATION WAS PROVIDED THAT A PATIENT UNDERWENT A PICC LINE PLACEMENT PROCEDURE. DURING THE PROCEDURE THE NEEDLE BROKE INSIDE THE PATIENT'S ARM. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED PAIN IN THE UPPER ARM AND NON OCCLUSIVE DVT DUE TO THIS EVENT.
Patient problems: Pain
MAUDE report 6036521 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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