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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

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COOK, INC. BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number HNR4.0-35-65-P-8S-VCF
Device Problem Tip breakage (1638)
Patient Problem Foreign body, removal of (2365)
Event Date 04/10/2014
Event Type  Injury  
Event Description
During a lower leg extremity angiogram on (b)(6) 2014 the catheter tip broke off.Device portion retrieved with no harm to the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information has been provided.
 
Manufacturer Narrative
(b)(4).Event evaluation - still under investigation.
 
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Brand Name
BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
Type of Device
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key3818111
MDR Text Key4500478
Report Number1820334-2014-00217
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2017
Device Catalogue NumberHNR4.0-35-65-P-8S-VCF
Device Lot Number4781832
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/10/2014
Device Age2 MO
Event Location Hospital
Initial Date Manufacturer Received 04/28/2014
Initial Date FDA Received05/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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