MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number N/A

Device Problems Flaked (1246); Unraveled Material (1664); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that an intern opened a fuhrman pleural / pneumopericardial drainage set to find that the wire guide inside was stripped.The wire guide was intended to be used for a pneumothorax release but ultimately, no patient contact was made and therefore no adverse effects occurred.The product was discarded and another was used in its place.Additional questions have been asked regarding details of the device, but are unavailable at the time of this report.

Manufacturer Narrative

Correction: h6 - device code.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.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

In additional information received on 03oct2019, it was reported that the user found the inner mandril of the wire guide to be protruding through the outer coiling, and around the mandril protrusion, the coil appeared to be slightly elongated.The affected portion of the wire guide was outside of the wire guide holder.The problem was found immediately upon opening the set and the device was not used on the patient.Images of the device were requested by the manufacturer, but were unable to be provided by the facility.

Event Description

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

Manufacturer Narrative

Investigation/evaluation: a review of the documentation including complaint history, device history record, manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The visual inspection of the complaint device could not be completed, as the device was not returned for evaluation.A similar device with the same reported failure mode was returned and examined for mfg.Report reference#: 1820334-2019-01725.The device was returned with most of the wire within the spiral holder, but with the damaged portion sticking out.The safety wire was observed to be separated and sticking out of an unraveled region of coiling.All dimensional measurements that could be taken were within the correct specifications and tolerances.The investigation concluded that a definitive cause for the failure could not be concluded, but it was possibly related to issues during the manufacturing process or excessive forced during shipping and handling.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file demonstrated that adequate risk controls are in place for all potential failure modes, and the analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record for lot: 9641179 revealed no related nonconformances.A database search revealed no other complaints have been reported for the complaint device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause was established as component failure without a design or manufacturing issue.It is possible the damage to the device occurred due to excessive forces experienced during shipping and handling of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8936118
• MDR Text Key: 155697379
• Report Number: 1820334-2019-02133
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002557154
• UDI-Public: (01)00827002557154(17)220403(10)9641179
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-850-WCE-IMH
• Device Lot Number: 9641179
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1