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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER
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COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number MPIS-401-NT-U-SST
Device Problems Material Frayed (1262); Kinked (1339); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2016
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
It was reported upon attempting to advance from the puncture site, the guide wire would not advance.It was noted upon removal from the patient¿s body, the device was kinked/frayed.Another device was used to complete the procedure.No adverse effect to the patient was reported.
 
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Brand Name
MICROPUNCTURE TRANSITIONLESS ACCESS SET
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 Key6737696
MDR Text Key81093836
Report Number1820334-2017-01943
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002479449
UDI-Public(01)00827002479449(17)181130(10)6415623
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMPIS-401-NT-U-SST
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
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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