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 Material Separation (1562)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: lead tech.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 used during a drainage procedure.The user reported initial placement was successful.However, as the drainage bag was attached the "entire mac-loc fell off." at the time of this report, it is unknown what actions were taken in response to the event.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

It was initially reported a ultrathane mac-loc locking loop multipurpose drainage catheter was used during a drainage procedure.The user reported initial placement was successful.However, as the drainage bag was attached the "entire mac-loc fell off." additional information was received on 25jun2019.The device was placed in the patient's abdomen.The mac-loc "fell off" after an unspecified number of hours.The patient required an additional procedure to remove device and replace with a similar drain.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: (b)(6) 2019.Investigation ¿ evaluation.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 and dimensional verification, were conducted during the investigation.The complaint device was returned to cook for investigation.During investigation, the hub and cap were confirmed separated from the tubing with the flare still intact, suggesting that the tubing was pulled through the hub.All dimensions relevant to the failure mode were analyzed and confirmed that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) found two nonconformances relevant to failure mode.All nonconforming products were scrapped, and all devices go through a 100% inspection for proximal end to catheter fit.A software search found no additional complaints from the field on the reported lot.Due to this information, there is no evidence suggesting that additional nonconforming product from this lot exists in house or in the field.Based on the information provided, inspection of returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures are being conducted to address this failure mode.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 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
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8627735
• MDR Text Key: 145637310
• Report Number: 1820334-2019-01250
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)220306(10)9573568
• 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,Followup
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 9573568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 07/08/2019
• Supplement Dates FDA Received: 06/26/2019; 07/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention