MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Suspect medical device: unknown mac-loc drainage catheter.Common device name: additional information has been requested but not yet received.Device available for evaluation: unknown.Occupation: unknown.Pma/510(k) #: product identity currently unknown, additional information has been requested.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

During investigation of an unrelated complaint, a photo was obtained of a different mac-loc drainage catheter showing a separation of the hub from the catheter.No further information is available at the time of this report.Additional information has been requested and follow-up will be sent upon receiving additional information.

Manufacturer Narrative

This report is being sent to indicate the complaint event is being canceled.Additional information was received that indicates this event was reported in error.On 22may2020, the customer indicated that the photo that initiated this complaint was a photo of the device reported under medwatch report # 1820334-2020-00870.Only one device experienced this failure.Only one report is necessary and all additional information regarding this event will be captured under medwatch report # 1820334-2020-00870.No follow up information will be submitted for this report.This complaint will be canceled by the manufacturer.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10079341
• MDR Text Key: 199990112
• Report Number: 1820334-2020-00979
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1