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

Catalog Number ULT8.5-38-25-P-6S-CLM-RH

Device Problem Aspiration Issue (2883)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported a ultrathane mac-loc locking loop multipurpose drainage catheter was placed and drew in air when aspirated.The device was removed and another like device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/ dimensional verification/functional test of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a leak between the catheter tubing and connector cap.Device attributes (number of threads showing between the mac-loc hub and connector cap, the mac-loc hub inner diameter, the connector cap inner diameter, and the catheter tubing outer diameter) were measured and found to be within manufacturing specifications.The device is not out of specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Ifu states: the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause has not been determined.However, this failure mode has been escalated per internal processes.We have notified the appropriate personnel and 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.

• Brand Name: ULTRATHANE 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: 7560054
• MDR Text Key: 109762163
• Report Number: 1820334-2018-01655
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)210222(10)8615996
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1