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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Manufacturer Narrative
Additional common name: ljs turbo-ject peripherally inserted central venous catheter. Additional product code: ljs. Occupation: other health care professional. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
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 discussed future options with the physician. The nurse stayed at the bedside to ensure that the clamp would stay in place. The team of physicians quickly made the decision to have the picc line pulled, which the nurse carried out shortly after. Minimal fluid was found where the patient was sitting, which indicated that the line probably broke not long after the patient's mother pressed the call light. The mother was noted to have been with the patient the entire time. It was reported that the nurse had been in the room 15 minutes prior and confirmed that there were no issues with the line. It was later noted that approximately 3ml of blood leaked from the line by the time the nurse got the atraumatic clamp placed in the correct location. It is currently unknown how the line developed a hole. The patient did not experience any adverse effects due to this occurrence. Additional information regarding event details has been requested, but is currently unavailable.
 
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Brand NameSPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13588610
MDR Text Key287590703
Report Number1820334-2022-00302
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002056763
UDI-Public(01)00827002056763(17)221201(10)13724268
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K100974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberN/A
Device Catalogue NumberUPICS-3.0-CT-NT-ABRM-1110
Device Lot Number13724268
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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