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

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).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 or Problem Description
It was reported an unknown patient required the placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a drainage procedure.After placement the operator reported that the drain began leaking from "where the lock and tube meet." the catheter was removed and another device of the same lot was placed, however it was reported to leak as well.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon return of the drainage catheters for visual examination it was determined that one of the leaking catheters was separated at the hub.The device that only leaked at the hub is reported under medwatch report #: 1820334-2020-01193 the device that separated at the hub and leaked is reported under the medwatch report with patient identifier (b)(4) (this report).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: section c.Additional method code: communication/interviews (4111).Investigation ¿ evaluation.Presbyterian hospital-dallas informed cook that on (b)(6) 2020 two ultrathane mac-loc locking loop multipurpose drainage catheters leaked from the hub during a procedure.This report addresses one of these devices.The patient did not experience adverse effects.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and supplier investigation, were conducted during the investigation.The customer returned the used catheter for investigation the device had cut catheter tubing.The device was broken at the mac-loc adapter threads.The threads are partially torn where they enter the connector cap.The device could not be leak tested and could not be measured due to damage.Additionally, a document based investigation evaluation was performed.Based on the review of current documentation, cook has concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: "how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots records no related nonconformances.A database search found one additional complaint on the lot.The additional complaint is a leakage complaint on a device used during the same procedure (reported under medwatch report #1820334-2020-01193).The investigation of the device from the related complaint was confirmed to have been manufactured out of specification, but that there is no evidence of additional nonconforming material in house or in the field.There is one additional complaint (reported under medwatch report #:1820334-2018-02462) on the supplied mac-loc hub raw material lot for two devices experiencing the same failure of broken adapter threads.The investigation for this complaint concluded component failure.Because there are 2 complaints on 3 devices from this supplier lot, cook requested a supplier investigation.Cook polymer technology completed a supplier investigation.A review of the injection molded lots that produced the parts identified in this complaint was conducted.No related nonconformances were identified in the injection lots used to manufacture the mac loc bodies.The tooling used to produce the parts in the identified lots had been previously qualified and ran on other work orders.Additionally, it was stated that there are not any indications that the product failed to meet specification.The supplier investigation concluded that there is no indication that supplier manufacturing contributed to the failure mode.Based on the information provided, examination of the returned product, the results of the supplier investigation and cook's investigation, the conclusion is component failure without design or manufacturing deficiency.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10340643
• Report Number: 1820334-2020-01380
• Device Sequence Number: 16888668
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)210305(10)8641859
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 8641859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1