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

Model Number G00166

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation - unknown.Pma/510k - 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, while checking a one-part percutaneous entry needle, it contained an unidentified particle within the primary packaging.Reportedly, this device did not come into contact with a patient.

Manufacturer Narrative

Investigation - evaluation.Reviews of the complaint history, device history record, manufacturer¿s instructions, quality control procedures, and a visual inspection of photos of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the device were provided.Upon examining these photos, a black spec was evident in the package near the seal.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed one nonconforming event which could have potentially contributed to this failure mode.However, while this was related to the reported failure, it should be noted that the affected units were scrapped and replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that this event could be traced to manufacturing and quality control.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9233026
• MDR Text Key: 176617677
• Report Number: 1820334-2019-02679
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002001664
• UDI-Public: (01)00827002001664(17)240506(10)9718021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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
• Device Operator: No Information
• Device Model Number: G00166
• Device Catalogue Number: SDN-18-7.0
• Device Lot Number: 9718021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1