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 Problem No Patient Involvement (2645)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Model #: rpn: ult7.0-35-25-p-5s-cldm-tong-050399.Initial reporter also sent report to fda: unknown.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 unknown patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an unknown procedure.Prior to patient contact, the operator flushed the catheter and noted a leak was noted between the hub and the catheter.The device was not used on the patient, and another similar device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

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

Manufacturer Narrative

D10 ¿ product received on: 04dec2019.Investigation ¿ evaluation: it was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked prior to patient contact.Reportedly the physician disassembled and cut the catheter in order to determine where the leak came from.Cook became aware of this event on upon being notified by a physician from (b)(6) hospital in japan.The patient reportedly experienced no adverse effects as a result of this incident.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.The complainant returned the device in a damaged condition.The tubing was cut so that only the proximal 2.9cm of tubing remained, and the tubing was already separated from the hub.Relevant tests such as tug, twist, and leak tests could not be performed due to the damage.The distance between the hub and cap was measured and was determined to be out of specification.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) was reviewed.The dhr of the lot and related subassembly lots revealed no nonconformances.A complaint database search revealed no other complaints from the lot at the time of the investigation.There is no evidence that there are nonconforming devices in house or out in the field.The instructions for use (ifu) supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.The returned device was determined to be out of specification for the distance between the hub and the cap.A capa was previously opened to address this issue and concluded that the main root cause was manufacturing-related.Corrective actions in the form of retraining and implementation of a gap gauge were performed.Based on the information provided, returned product evaluation, and as the reported lot was manufactured prior to corrective action implementation, it was concluded that a manufacturing and quality control deficiency contributed to this incident.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: 9348649
• MDR Text Key: 177636701
• Report Number: 1820334-2019-02926
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002128767
• UDI-Public: (01)00827002128767(17)220521(10)NS9757104
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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: 05/21/2022
• Device Model Number: N/A
• Device Lot Number: NS9757104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1