MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: event occurred sometime in (b)(6) 2019.Suspect medical device: product information currently unavailable.Reported as mac-loc multipurpose drain.Occupation: ir technician.Pma/510(k) #: unknown.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 an unknown patient required the placement of a mac-loc multipurpose drain for an unknown procedure.As reported, the catheter separated at the hub and "the drain came out of the flare fitting." additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction - h6 - device code desc 1/ device code 1.H6 ¿ method code: device not returned (4114).Investigation - evaluation: a review of documentation including the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination could not be performed.However, a document-based investigation evaluation was conducted.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record could not be performed, as lot and rpn information was not provided by the facility.The ifu supplied with the mac-loc drainage catheters instruct that ¿the product should be inspected prior to use to ensure no damage has occurred.¿ based on the information provided, no returned product and the results of our investigation, a definitive root cause can be traced to manufacturing and a quality control deficiency.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Additional information: b3 (date of event), b5 (event).B5: event description: additional information regarding event details was received on 05nov2019.The device was in place for five days before the separation occurred.The device was connected to a drainage bulb.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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9109532
• MDR Text Key: 176456122
• Report Number: 1820334-2019-02397
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 11/21/2019
• Supplement Dates FDA Received: 11/07/2019; 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1