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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: pharmaceutical.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 or Problem Description
It was reported a patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an unknown procedure.While the operator was removing the device from the packaging, the tip was noted to be "a little bent." the device was described as breaking before it was able to be used on the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was provided on 28jun2021.It was reported that the procedure was completed with a drain of the same size.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.Agility logistics contacted cook regarding a complaint on one ult10.2-38-25-o-5s-cldm-hc from lot# 10087750 occurring in brazil.The tip was bent and then broke upon removal from the package.No part of the device contacted the patient and another device was used to complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.No photos were taken to aid in investigation and evaluation.However, a document based investigation evaluation was performed.The device master record (dmr) was reviewed.The device is 100% inspected for defects.The design history file contains controls related to the reported failure.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot did not find any relevant nonconformances.There are no additional complaints on this lot.There is no evidence of non-conforming material in house or in the field.Instruction for use document [t_multi-rev5] is packaged with this device.It is stated: upon removal from package, inspect the product to ensure no damage has occurred.Based on the device failure analysis, device history record, and device master record, there is no indication the device was manufactured out of specification.Based on the information provided and the results of the investigation, the most likely cause of damage was transport/storage.The appropriate internal personnel have been notified.Per the 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
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11655643
• Report Number: 1820334-2021-01127
• Device Sequence Number: 19734503
• Product Code: GBO
• UDI-Device Identifier: 00827002097063
• UDI-Public: (01)00827002097063(17)221016(10)10087750
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: 10087750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 02/21/2022
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/29/2021; 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown