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

Model Number G00280

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

As reported, prior to use for an unknown procedure, foreign matter described as a tiny insect was noted on a one-part percutaneous entry needle's outer sheath when the device was opened on the sterile field.There have been no reported adverse effects to the patient.

Manufacturer Narrative

It is unknown if the device will be returned.Customer address line 2: (b)(6).Postal: (b)(6).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.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 Description

Additional information was received 01mar2023.A photo provided by the customer shows a small insect on the outside of the needle cover.The device did not get near the patient.The patient did not require any additional procedures or experience any adverse effects due to this event.

Manufacturer Narrative

Corrected information: d9, h3= information that the device would be returned was available and inadvertently omitted from the initial mdr.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 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.

Manufacturer Narrative

Summary of event: as reported, prior to use for an unknown procedure, foreign matter described as a tiny insect was noted on a one-part percutaneous entry needle's outer sheath when the device was opened on the sterile field.There have been no reported adverse effects to the patient.Additional information was received 01mar2023.A photo provided by the customer shows a small insect on the outside of the needle cover.The device did not get near the patient.The patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, quality control procedures, inspection of unused product, and a visual examination of the complaint device were conducted during the investigation.The complainant returned one prior to use and 9 sealed sdn-21-4.0 to cook for investigation.Physical examination of the returned devices showed: one insect was noted alongside the needle inside a plastic bag, not the cook packaging.No other insects were present in the nine sealed packages.A review of the device history record found a relevant non-conformance for ¿foreign matter¿ quantity 6.A database search for complaints on the reported lot found no additional lot related complaints from the field.Although there are non-conformances relevant to the reported failure mode, all non-conforming product was reworked, and there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, and there are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.This product is not shipped with an ifu (instructions for use).A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that a manufacturing and quality control deficiency contributed to the failure mode.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 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
• 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: 16312336
• MDR Text Key: 309141275
• Report Number: 1820334-2023-00103
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002002807
• UDI-Public: (01)00827002002807(17)270607(10)14773282
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G00280
• Device Catalogue Number: SDN-21-4.0
• Device Lot Number: 14773282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1