• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DQY CATHETER, PERCUTANEOUS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number G02854
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2019
Event Type  Malfunction  
Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged. Pma/510(k) #: preamendment. Investigation - evaluation. A customer at seton dell children's hospital (united states) reported that the needle in a c-pmsy-250 (single lumen polyethylene central venous catheter tray) from lot 9402033 did not give blood return during an arterial pressure monitoring procedure on (b)(6) 2019. The customer stated that when they inserted the needle, they did not get "flashback" and had difficulty inserting the wire guide through the needle. The patient did not experience adverse effects. A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation. One used 22g needle was returned to cook for evaluation. Upon visual inspection, no damage or biomatter was noted. A functional test found that the needle was able to be flushed without difficulty. Additionally, a document-based investigation evaluation was performed. The device master record (dmr) found that proper procedures and inspections are in place to prevent the distribution of non-conforming product. A review of the device's design history files found that the product is both safe and effective for its intended use. A review of the dhrs for the reported complaint device lot (9402033) and the related needle component lot revealed no recorded non-conformances. A database search did not find any other events associated with the reported device lot. However, based on the dhr review, there is evidence of potential nonconforming material in house and in field. As the needle is supplied by cook polymer technology (cpt), cook initiated a supplier corrective action request in response to this issue. As there is evidence of potentially nonconforming material from the same supplier lots in other events, cook initiated product containment for affected in house product and to prevent redistribution of product in the field. It should be noted that there was one additional event reported to cook associated with the complaint device lot. Cook also reviewed product labeling. The instructions for use [ifu_t_ulmbhce_rev6] state "upon removal from package, inspect the product to ensure no damage has occurred. " based on the information provided, no returned product, and the results of our investigation, a definitive root cause was established as a deficiency in supplier manufacturing/quality control. The appropriate personnel have been notified. Cook will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.

 
Event Description

It was reported that the needle of a single lumen polyethylene central venous catheter tray did not give blood return during an arterial pressure monitoring procedure. After insertion, saline was flushed through the needle and the wire guide was attempted to be advanced through the needle. When the user inserted the needle, they did not get "flashback" and experienced difficulty inserting the wire guide through the needle. It was stated that "it is suspected that the vessel had not been accessed". The patient was already in the icu at the time of the event and was receiving the device for arterial pressure monitoring. A new kit was used to complete the procedure. No adverse effects to the patient have been reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9959067
MDR Text Key201913132
Report Number1820334-2020-00813
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 04/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG02854
Device Catalogue NumberC-PMSY-250
Device LOT Number9402033
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-