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 Problem No Code Available (3191)

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 an unknown patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for nephrostomy drainage.The catheter was placed and sometime later the patient returned with the catheter disconnected at the mac-loc.The catheter was exchanged for another similar device without any problems.No adverse effects were reported.

Manufacturer Narrative

Additional information/correction: this complaint is being canceled.Additional information was received that indicates this event was reported in error.Additional information received on 13jan2021 indicates this report is a duplicate of medwatch report #1820334-2020-02359.The customer only reported one patient and one device failed and all previously reported incidents have been reported.All additional information and investigation will be reported under medwatch report #1820334-2020-02359.No follow up information will be submitted for this report.This complaint will be canceled by the manufacturer.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.

• 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: 11088159
• MDR Text Key: 224090928
• Report Number: 1820334-2020-02370
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention