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 Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.Rpn: ult10.2-38-25-p-5s-cldm-tong-050399.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 Description

It was reported the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was not sealed properly.The outer packaging was not sealed underneath at one end.The catheter did not make patient contact and no other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on (b)(6) 2022 cook korea received a complaint from dr.Kim hui-jin, a representative at the daegu fatima hospital, located in korea, republic.Prior the the procedure, it was discovered the package containing an ult10.2-38-25-p-5s-cldm-tong-050399, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from lot number 13296583 was missing the seal, located opposite to the chevron end.Reviews of the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), and instructions for use (ifu) of the device, as well as an interview of personnel, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Additionally, cook completed a review of the dhr for lots that were packaged and sealed by the same operator as the complaint device lot within the same timeframe.The dhr for those 26 lots revealed no relevant non-conformances and no related complaints.At this time, cook concluded this event was an isolated incident regarding "missing seal" and that no additional non-conforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: how supplied ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded a manufacturing /qc deficiency contributed to this incident.Based on customer testimony and provided images the complaint device was not packaged to specification.The responsible personnel was retrained to prevent this failure from occurring again in the future.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 or that a death or serious injury occurred; nor is it admission 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
• 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: 15396276
• MDR Text Key: 299943472
• Report Number: 1820334-2022-01476
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002123854
• UDI-Public: (01)00827002123854(17)230710(10)13296583
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: 07/10/2023
• Device Model Number: N/A
• Device Lot Number: 13296583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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