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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-38-40-RB-BLKN
Device Problems Material Too Rigid or Stiff (1544); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
The complainant noted that the tip of the device was too stiff for the angio catheter to enter. Upon further review of this product problem, it was noted that the dilator tip was split. This product problem occurred prior to patient contact so no adverse effects to the patient were reported.
 
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Brand NameFLEXOR BALKIN GUIDING SHEATH
Type of DeviceDYB 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 Key6570216
MDR Text Key75441228
Report Number1820334-2017-01152
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002103832
UDI-Public(01)00827002103832(17)170808(10)5197571
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial
Report Date 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKCFW-6.0-38-40-RB-BLKN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2014
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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