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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 Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2019
Event Type  Injury  
Manufacturer Narrative
Occupation: risk analyst. Pma/510(k) #: k100974. 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 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.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8472731
MDR Text Key140612733
Report Number1820334-2019-00826
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2020
Device Model NumberN/A
Device Catalogue NumberUPICS-3.0-CT-NT-ABRM-1110
Device Lot Number9112705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/02/2019 Patient Sequence Number: 1
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