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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Type  Injury  
Manufacturer Narrative
Journal article: moissenet, didler, et. Al. (2012) persistent bloodstream with kocuria rhizophila related to a damaged central catheter. Journal of clinical microbiology p. 1495 - 1498. (b)(4). Event is still under investigation.
 
Event Description
Per the alleged journal article, the patient was a (b)(6) female with total colonic form of hirschsprung's disease. On day 2 of her life ((b)(6) 2006), an emergency surgery for small intestine occlusion due to atresia was performed, which removal of 31cm of small intestine, followed by terminal ileostomy and colostomy. On (b)(6) 2006, a cook spectrum central venous catheter was placed for home parenteral nutrition after an accidental removal of another manufacturer's catheter. Four months later ((b)(6) 2006), the first septic episode was observed, with seven positive blood samples drawn through the catheter and from a peripheral vein. The fever resolved promptly after the initiation of antimicrobial therapy. Persistent bloodstream infection with kocuria rhizophila was identified. At the time of the last septic event in 2009, a hole in the catheter was detected and repaired using a specific repairing kit (which had been placed after the accidental removal of the other manufacturer's catheter). After (b)(6) 2009, no novel septic episode was observed.
 
Manufacturer Narrative
Journal article: moissenet, didler, et. Al. (2012) persistent bloodstream with kocuria rhizophila related to a damaged central catheter. Journal of clinical microbiology p. 1495 - 1498. (b)(4). Investigation - evaluation: a review of the complaint history, drawings, documentation, instructions for use (ifu), manufacturing instructions, specifications and quality control was conducted during the investigation. The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the device is packaged with the ifu which states the precaution, ¿these products are intended for physicians trained and experienced in the placement of central venous catheters. ¿ ¿strict aseptic technique must be adhered to while using and maintaining the catheter. ¿ the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. Review of device history record and non-conformances was not able to be completed as the lot number was not available. The repeated removal and replacement of catheters described in the description of event tab may be related to the cause of the infection, but cannot be confirmed as the root cause of the event. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
Event Description
Per the alleged journal article, the patient was a (b)(6) female with total colonic form of hirschsprung's disease. On (b)(6) ((b)(6) 2006), an emergency surgery for small intestine occlusion due to atresia was performed, which removal of 31cm of small intestine, followed by terminal ileostomy and colostomy. On (b)(6) 2006, a cook spectrum central venous catheter was placed for home parenteral nutrition after an accidental removal of another manufacturer's catheter. Four months later ((b)(6) 2006), the first septic episode was observed, with seven positive blood samples drawn through the catheter and from a peripheral vein. The fever resolved promptly after the initiation of antimicrobial therapy. Persistent bloodstream infection with kocuria rhizophila was identified. At the time of the last septic event in 2009, a hole in the catheter was detected and repaired using a specific repairing kit (which had been placed after the accidental removal of the other manufacturer's catheter). After (b)(6) 2009, no novel septic episode was observed.
 
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Brand NameCENTRAL VENOUS CATHETER SET
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key5722746
MDR Text Key47311285
Report Number1820334-2016-00419
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received05/20/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/14/2016 Patient Sequence Number: 1
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