MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation: unknown.Occupation: facilities lead.Pma/510(k) #: exempt.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 ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was used in an unknown patient for an unknown procedure.The medical staff found the device was leaking between the catheter and the hub.A second device of the same kind was used and found to be leaking at the same location.It is currently unknown how the procedure was completed.Additional information regarding the event and patient outcome is currently unavailable.

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.

Event Description

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

Manufacturer Narrative

Additional information: b5 - event description: additional information was provided on 31jul2019.The complaint devices were used for thoracentesis procedures.The procedure was completed by exchanging catheters.The patient did not experience any adverse events.H6 - patient code: updated to "no known impact or consequence to patient (b)(6)." 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.

Event Description

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

Manufacturer Narrative

Correction: d4: the lot originally reported was determined to be incorrectly associated with this complaint.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.

Event Description

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

Manufacturer Narrative

Concomitant medical product received on: 20aug2019.Investigation-evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.For this complaint, two used and 1 unused device were returned for investigation.Slight biomatter was noted on the surface of the used devices.No damage was observed.For both used devices, the distance measurement between the hub and cap was determined to be out of specification.Tug and twist testing on the catheter tubing demonstrated the used catheters were able to twist.Leakage was confirmed between connector cap and tubing on both devices.The flares appeared slightly shallow, but undamaged and the sutures were normal within the threads.Devices 1 and 2 were dimensionally measured, showing they were within the correct specifications and tolerances for the connector cap inner diameter, the mac-loc hub inner diameter, and the catheter tubing outer diameter.Visual inspection of the number of threads showing revealed it was out of specification.The unused device was also returned sealed within the original packaging.It was removed from the package and inspected, but no damage was observed.The device was leak tested, but no leak was observed.Additionally, 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.Instructions for use (ifu) were reviewed.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.Review of the device history record (dhr) was completed.The dhr for the complaint lot and related subassembly lots revealed no reported nonconformances.A search of reporting software confirmed that seven other complaints are associated with this complaint lot.All of these complaints were either reported from the field for leakage or were opened due to leakage of returned unused devices from the field.Based on this information, there is evidence that nonconforming product exists out in the field.Based on the information provided, inspection of the returned product and the results of the investigation, cook has concluded that a manufacturing and quality control deficiency contributed to this incident.Corrective actions including implementation of a gap gauge and retraining were performed.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.Cook 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.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8832305
• MDR Text Key: 152378689
• Report Number: 1820334-2019-01811
• 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,Followup,Followup
• Report Date: 01/16/2020

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 Expiration Date: 06/10/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT6.3-35-15-P-5S-CLDM-HC
• Device Lot Number: 9799196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 08/21/2019; 09/17/2019; 01/06/2020
• Supplement Dates FDA Received: 08/02/2019; 08/26/2019; 09/23/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1