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 Type  malfunction  

Manufacturer Narrative

Date of event: event occurred sometime in (b)(6) 2019.Suspect medical device: product information currently unavailable.Reported as a mac-loc multipurpose drain device.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 placement of a mac-loc multipurpose drainage device for an unknown procedure.As reported, the catheter separated from the hub of the device 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

Correction: h6 - device code 1.Additional methods code: device not returned (4114).Investigation/evaluation: a review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook received a complaint for a similar product experiencing a similar failure mode in medwatch report#: 1820334-2019-01341.The physical examination of the complaint device in medwatch report#: 1820334-2019-01341 found the hub separated from the tubing, but it was confirmed that the device was manufactured within specification.Based on the information available at this time, there is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.A document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.Cook could not complete a review of the dhr for this complaint as the lot number and rpn weren¿t known.A search for all lots sold to the customer during the device¿s shelf life could not be completed as the rpn was unknown and the only information given was ¿mac-loc multipurpose drain¿.Due to the missing information, a data base search for complaints on the affected lot could not be completed either, thus there is no evidence of nonconforming product from the affected lot in house or in the field.Based on the information provided, no examination of returned product and the results of the investigation, it was concluded that a manufacturing deficiency and quality control deficiency caused or contributed to this failure.Corrective actions including implementation of a gap gauge and retraining were performed.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.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9109534
• MDR Text Key: 176455550
• Report Number: 1820334-2019-02398
• 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
• Report Date: 12/04/2019

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: 11/21/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1