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

Model Number	N/A
Medical Device Problem Code	Split (2537)
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
Customer reported that the catheter of a yueh centesis disposable catheter needle split during an abdominal aspiration procedure.The device was connected and was sucking in air at the split on the proximal end of the device.Another device was obtained to complete the aspiration.There are no reported adverse patient consequences.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, dimensional verification, device history record, documentation, drawing, quality control data and visual inspection was conducted during the investigation.Visual inspection of the returned device was performed.Pictures of the device showed the proximal end of the catheter and needle bevel, showing a catheter shaving on the bevel of the needle.A device failure analysis revealed that there was a split about 8 mm distal to the hub of the catheter.It is possible that the needle was inserted at a sharp angle, resulting in a puncture in the catheter and the shaving in the bevel.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and four (4) nonconformances were found.However, the reported non-conformances were not related to the reported failure, and all nonconforming packages were reworked.A review of complaint history search revealed one (1) additional complaint which was not related to this issue.Based on the provided information and evaluation of the returned device, the root cause is determined to be product use or handling related - user technique.Based on the description and failure analysis findings, it's possible that the catheter was punctured during needle insertion.As a result, a hole was produced in the catheter near the hub, and the shaving of catheter on the needle was produced.The risk analysis for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.We will continue to monitor for similar complaints.

• 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: 6721171
• Report Number: 1820334-2017-01753
• Device Sequence Number: 11166700
• Product Code: GCB
• UDI-Device Identifier: 00827002094901
• UDI-Public: (01)00827002094901(17)200419(10)7843321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DTVN-5.0-19-10.0-YUEH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1