MAUDE Adverse Event Report: COOK INC UNKNOWN; DQY CATHETER, PERCUTANEOUS

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Common device name: not available as the identity of the device is unknown.Product lot #/product lot # (mdr): the lot for this device was reported to be 18f033d.However, this is not a registered cook lot number.Information to clarify has been requested but not provided at this time.Customer (person): postal code: (b)(6).Country: (b)(6).Occupation: not available as the identity of the device is unknown.Pma/510(k): preamendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the line of an unknown cook right arterial line, single lumen sutured catheter device had to be cut.In the process, a portion of the line was left inside the patient.The patient was hospitalized at the time of the event.The line was being removed "per protocol" when significant resistance was felt.Consequently, the line had to be cut, leaving a portion inside of the patient.Upon assessment, the portion retained by the patient was found to be extracardiac and was therefore left inside the patient.No other adverse effects to the patient have been reported.

Manufacturer Narrative

Common device name: the exact rpn of the device is unknown but for this product line, possible procodes are dqo and dqy.Correction: occupation: interim quality program lead.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

No additional patient/event information has been received since the previous medwatch report was sent.

Event Description

Information was received on 06aug2020 confirming that this event did not involve a cook device.No further reports involving this event will be submitted by cook inc.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNKNOWN
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10350287
• MDR Text Key: 201582834
• Report Number: 1820334-2020-01400
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other