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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC

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COOK INC Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problems Blood Loss (2597); No Code Available (3191)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray. Investigation - evaluation: a review of the complaint history, documentation, drawing, instructions for use(ifu), manufacturing instructions, specifications, quality control data, dimensional verification, and visual inspection of the returned device were conducted during the investigation. Visual inspection and dimensional verification of the returned device were performed. Measurements of the component in question were performed and it was found that the device was manufactured to specification. The reported failure could not be duplicated even though it was observed the extension tube labeled "distal" was separated from the manifold-hub of the catheter. The complainant device lot number is unknown. Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted. However, a document-based investigation evaluation showed no evidence to suggest the product was not made to specifications. Based on the provided information, inspection of returned product, and the investigation results, the root cause is related to the circumstances during cardioversion/defibrillation. We will notify the appropriate personnel and continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray. (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event Description
The customer reported that, during an unknown procedure, the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray was used. While delivering cardioversion/defibrillation (no cardiopulmonary resuscitation); blood was noted behind the patient shoulder; when investigating, the middle lumen was found to be detached and port leaking blood (around 15 cm in diameter). Staff witnesses do not recall seeing the tubing/catheter trapped or pulled by a side rail or being in tension. The leak was controlled by placing an occlusive transparent dressing to prevent air from getting in. Therapy (norepinephrine and vasopressin) was switched to pre-existing femoral dialysis catheter and the involved 3-lumen catheter was removed and saved for investigation. Placement of a left subclavian introducer and pa catheter for vasopressor therapy access and hemodynamic monitoring was performed. As of the date of this report, product has not been received for evaluation.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key6894894
MDR Text Key255786136
Report Number1820334-2017-03258
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-UTLMY-701J-ABRM-CUSTOM-0020
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 Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/26/2017 Patient Sequence Number: 1