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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510k status: exempt.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that, three days following the placement of the ultrathane mac-loc locking loop multipurpose drainage catheter, it was discovered that the hub detached.This issue necessitated the replacement of the device with a new product.Additional information was requested from the customer, but none has yet been made available.The device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

A review of the drawings, documentation, instructions for use (ifu), manufacturing instructions, and quality control, was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a photo was supplied which shows the flared tubing outside of the cap of the proximal assembly.The flare appears to be concentric.The complainant device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.The manufacturing documents in place at the time of manufacture were reviewed, and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.However, appropriate measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7126830
• MDR Text Key: 95165608
• Report Number: 1820334-2017-04454
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention