MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient received an ultrathane mac-loc locking loop multipurpose drainage catheter on (b)(6) 2017 for unspecified drainage.The hub fell off the device on (b)(6) 2017.The circumstances and handling conditions leading to the event are not known.The device was completely explanted and replaced with a new catheter.No further information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control data was conducted during the investigation.During the manufacturing process the cap is pulled over flare until flare is seated against inside bottom of cap.The adapter is then attached to the cap and adhesive is applied to the threads of the adapter to prevent the cap and adaptor from reverse threading.The proximal fitting and tubing diameter are checked during quality control inspection.The device is shipped with an ifu which outlines the potential adverse effects, warnings, and precautions to take when operating the device.A complaint record search showed this was the only complaint related to the lot number and no nonconformances were found on the work order.The device was not returned for further investigation, so there was no evidence to suggest the product was manufactured out of specification.There was no evidence to suggest the product was nonconforming in house or the field.There is no conclusive evidence to suggest the hub fell off due to environmental conditions, so the root cause was deemed inconclusive.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ULTRATHANE 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
• MDR Report Key: 6683945
• Report Number: 1820334-2017-01650
• Device Sequence Number: 11277632
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)200123(10)7611760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-45-P-6S-CLM-RH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention