MAUDE Adverse Event Report: COOK INC YUEH CENTESIS DISPOSABLE CATHETER NEEDLE; GCB NEEDLE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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
The customer reported that, when using the yueh centesis disposable catheter needle inside the patient during a thoracentesis, it was identified that approximately 1 cm of the tip of the catheter had broken, and appeared to be permanently bent.This was discovered after the needle was removed from the device, and no fluid returned as expected.The circumstances surrounding the usage and handling of the device are not known.The customer confirmed that no pieces of the catheter remained in the patient, and no additional procedures were necessary as a result of the issue.The patient reportedly did not experience any adverse events as a result of the product problem.The product is reportedly not available for return.
Additional Manufacturer Narrative
The catheter part of the device was bent.It was not completely severed, but parts of the bent area were no longer attached.The radiologist did not believe that any pieces broke off inside the patient.A new yueh catheter device was opened and used instead of the broken one.510(k): preamendment.A review of the complaint history, device history record, documentation, drawing, quality control, specifications, and photo inspection of the device was completed during this investigation.The complaint device was not returned; therefore no physical examination could be performed.The device history record was reviewed and noted a total of three non-conformances within the packaging department were recorded and listed as, "applied incorrectly labels, seal burnt, and foreign matter".These nonconformances are not related to the reported failure.These non-conformances were reworked prior to further processing.A further search for additional complaints revealed this to be the only complaint for this lot number.The product was not returned.Based on the provided photos, the distal end of the catheter has been bent and appears to have also fractured.Risk controls are in place to mitigate risk of this failure mode.Since the user stated that the catheter was found to be bent after insertion and there is no available evidence to suggest that the product was not manufactured to current specifications, it is possible that the catheter bending and fracture occurred due to patient anatomy or user technique.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.

• Brand Name: YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
• Common Device Name: GCB NEEDLE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6902053
• Report Number: 1820334-2017-03437
• Device Sequence Number: 538344
• Product Code: GCB
• UDI-Device Identifier: 00827002094925
• UDI-Public: (01)00827002094925(17)200615(10)7993112
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DTVN-5.0-19-15.0-YUEH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1