MAUDE Adverse Event Report: COOK INC PARK PERICARDIOCENTESIS CATHETER TRAY; GBX CATHETER, IRRIGATION

Model Number G10215

Device Problems Break (1069); Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

As reported, upon opening the package of a park pericardiocentesis catheter tray prior to use, the user found that the lidocaine ampule was broken and the needle driver was "contaminated".A photo provided by the customer shows a brown/orange substance on the needle driver.No device from the tray made patient contact.The device had been stored in a pyxis.Another device of the same type was used to successfully complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, upon opening the package of a park pericardiocentesis catheter tray prior to use, the user found that the lidocaine ampule was broken and the needle driver was "contaminated".A photo provided by the customer shows a brown/orange substance on the needle driver.No device from the tray made patient contact.The device had been stored in a pyxis.Another device of the same type was used to successfully complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A photo provided by the user appears to show that the forceps in the package have been contaminated by the liquid coming out of the broken lidocaine container and have started to rust.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that the lidocaine vial break was likely caused by the transport and/or storage of the device.Cook will continue monitoring of similar complaints and has 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 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.

• Brand Name: PARK PERICARDIOCENTESIS CATHETER TRAY
• Type of Device: GBX CATHETER, IRRIGATION
• 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: 13266451
• MDR Text Key: 290160314
• Report Number: 1820334-2022-00067
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002102156
• UDI-Public: (01)00827002102156(17)220701(10)13761708
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: G10215
• Device Catalogue Number: PCSY-500-PARK-CARD
• Device Lot Number: 13761708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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