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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yueh centesis disposable catheter needle broke at the hub during a percutaneous abscess drainage procedure on a 73-year-old male patient.The user opened a new device to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.A photo provided by the customer confirms detachment of the hub from the catheter.
Additional Manufacturer Narrative
(b)(6).Pma/510(k): exempt.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation a representative of china medical university hospital (taiwan) informed cook on (b)(6) 2022 of an issue with a yueh centesis disposable catheter needle (rpn: dtvn-5.0-19-15.0-yueh; lot #: 13391496).It was reported that the device broke at the hub during a percutaneous abscess drainage procedure on a 73-year-old male patient.The user opened a new device to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One used device was received.The hub appears to have snapped into two pieces.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 13391496 found no additional complaints or nonconformances.Cook requested that the supplier investigate this occurrence.The device history record showed that the affected lot was released accomplishing all quality standard requirements.There was no deviation and no non-conformances reported during the manufacturing of this product.A review of the internal manufacturing device record, raw material history files and sub assembly catheter hub part number and the reported lot number was conducted, and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.Based on the dmr, dhr, device evaluation, and supplier investigation, there is no indication the complaint device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook reviewed product labeling.This device is not currently packaged with instructions for use.Based on the information provided, inspection of the returned device, and the results of the investigation, cook could not establish a cause for this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
• Common Device Name: GCB NEEDLE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15324541
• Report Number: 1820334-2022-01426
• Device Sequence Number: 5505751
• Product Code: GCB
• UDI-Device Identifier: 00827002094925
• UDI-Public: (01)00827002094925(17)230826(10)13391496
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Expiration Date: 08/26/2023
• Device Model Number: N/A
• Device Catalogue Number: DTVN-5.0-19-15.0-YUEH
• Device Lot Number: 13391496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 71 KG