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 Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 female patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for drainage of pleural effusion.The device was placed successfully.The next day, the patient found the hub of the drainage catheter was broken.The device was removed and a similar device was placed.Photos provided by the customer showed separation at the hub.No other adverse effects were reported for this incident.

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 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 unchanged, unknown, or unavailable.Investigation ¿ evaluation on 04feb2021, cook china received a complaint from (b)(6) medical tech.The customer reported that a 44-year-old female patient required the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult7.0-35-25-p-5s-cldm-hc, product lot number: 13157698).The initial procedure and placement was successful.The day following the procedure, the patient noted the catheter hub had separated from the tubing.The device was removed from the patient and another similar device was placed to continue treatment.No adverse events were reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection of a photo provided by the customer, were conducted during the investigation.The device was not returned for evaluation.However, photos were provided by the customer showing hub separation from drainage catheter.Additionally, a document based investigation evaluation was performed.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the 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.Based on the review of current documentation, cook has concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.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 found no related nonconformances.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house, in the field and that device was manufactured to current specification.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.Based on the information provided and the results of the investigation, the root cause category was traced to a component failure without any design or manufacturing issue.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.

Event Description

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

• 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: 11353344
• MDR Text Key: 241478261
• Report Number: 1820334-2021-00361
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)230427(10)13157698
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

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: 04/27/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 13157698
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 10/05/2021
• Supplement Dates FDA Received: 03/03/2021; 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 55