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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER
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COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-12.0-35-45-RB-HFANL1-HC
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The complainant alleged that the sterility of the package was compromised as a result of the stop cock puncturing through the package.This product problem was noted prior to patient contact.
 
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Brand Name
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
Type of Device
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6562089
MDR Text Key75151247
Report Number1820334-2017-01144
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002477018
UDI-Public(01)00827002477018(17)170201(10)4773734
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberKCFW-12.0-35-45-RB-HFANL1-HC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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