MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number G00003

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) number = exempt.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 the one-part percutaneous entry needle was noted to be bent as it was removed from it's packaging.The device was not used during a procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the needle was bent at a 60 degree angle.The bend was approximately 3.6 cm from the glue mount.A 0.018 inch diameter wire guide would not pass through the cannula; the wire would not advance past the bend.The shipping protector was also found to be fractured.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7492090
• MDR Text Key: 107572472
• Report Number: 1820334-2018-01046
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002000032
• UDI-Public: (01)00827002000032(17)220803(10)8115367
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G00003
• Device Catalogue Number: BSDN-18-7.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1