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 Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.Occupation: equipment and product standardisation nurse (skin and wound) ¿ supply chain management.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 number of ultrathane mac-loc locking loop multipurpose drainage catheters were unable to be inserted during nephrostomy tube changes.Additional information regarding the event, quantity of devices, failure mode, and patient outcome has been requested but is currently unavailable.

Event Description

See h10.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.The customer previously indicated that the catheter was unable to be inserted.Clarification was received (b)(6) 2020 stating that it was the flexible stiffener that could not be advanced into the catheter.There is no information confirming device malfunction or serious injury.Replacement of device to complete procedure is negligible harm and does not meet the criteria for a reportable event.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.

• 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: 9958177
• MDR Text Key: 199267053
• Report Number: 1820334-2020-00810
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)220905(10)9992711
• 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: 04/28/2020

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: 09/05/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 9992711
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1