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 Problems Leak/Splash (1354); Aspiration Issue (2883)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 on (b)(6) 2018 one 8.5fr 25cm multipurpose drain was defective during a breast seroma drainage.As reported, there was not a proper seal between the catheter and the luer adaptor, which introduced air into the system.This air infiltration would not introduce elevated risk to the patient.The connection was inspected and an attempt to disconnect and reconnect the luer adapter from the catheter was unsuccessful.The tube was then cut and a drain exchange was performed with a new device.The device was returned and tested on (b)(6) 2018.Bench testing indicated a leak occurred at the hub of the device.This device malfunction has the potential to cause or contribute to patient harm.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed one 8.5french mac-loc catheter in a partial and damaged condition.The device consisted of the mac-loc hub, connector cap, and approximately 4.5cm of catheter tubing ending with a cut.The remaining catheter tubing was not returned.There was a small amount of bio matter on the mac-loc hub.The number of adapter threads showing between the cap and hub exceeded those in the manufacturing instructions.Due to the difficulty removing the cap, it can be concluded that the device was manufactured out of specification.A leak test was performed and confirmed the presence of a leak between the connector cap and catheter tubing.Upon removal of the cap, it was clear that suture string was bunched up inside the cap threads.The flare was out of round, deformed, and possibly missing a portion.Due to the compression of the flare within the cap and potential damage upon removal, it cannot be determined if the flare was manufactured out of specification.Additionally, a document based investigation evaluation was performed.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.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause has been determined to be manufacturing related.Measures have been previously initiated to address this failure mode.The appropriate personnel have been notified, we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required at this time.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.

• 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: 7639522
• MDR Text Key: 112465637
• Report Number: 1820334-2018-01729
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)210122(10)8527019
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 8527019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1