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

Catalog Number SDN-18-5.0

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation = unknown.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

As reported, prior to patient contact, what was described as a "squashed bug" was noted inside the sealed packaging of a one-part percutaneous entry needle.The device did not make contact with any patient.

Manufacturer Narrative

Investigation - evaluation.Reviews of the complaint history, device history record, manufacturing instructions, specifications, and quality control procedures, as well as a visual inspection of the returned device were conducted during the investigation.The visual inspection of the unopened returned device confirmed an unknown foreign matter inside the sealed package.No other defects were observed.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed two nonconforming events related to this failure mode, both of which, however, were reworked before final processing.It should be noted there were no other reported complaints for this lot number.No evidence was revealed to suggest that any nonconforming product remains in house or in the field.Reviews of the manufacturer¿s instructions, specifications, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that no cause could be established for the failure mode.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: 8812755
• MDR Text Key: 151765157
• Report Number: 1820334-2019-01748
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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: Health Professional
• Device Catalogue Number: SDN-18-5.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1