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

Model Number G55723

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: 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 that before placement of a drain for an ascites puncture, the wire guide of a fuhrman pleural/pneumopericardial drainage set was "bent" in the packaging prior to patient contact.When the device was returned, it was noted to be separated, thus prompting this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.On 26mar2021, cook received a complaint from chu de toulouse ¿ logipharma facility in france stating that upon opening the amplatz wire guide in a c-ppd-850-imh (fuhrman pleural/pneumopericardial drainage set) from lot 10294422, the wire guide was bent.The device reportedly did not make patient contact.A review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, was conducted during the investigation.The supplied thscf-28-40-2-aes, amplatz wire guide from the c-ppd-850-imh, fuhrman pleural/pneumopericardial drainage set was returned in an opened and damaged condition.The wire guide coil was separated on the distal portion of the guide, but the mandril wire and welds were still intact.Although the distal and proximal weld connections were intact (attached to coil), the reported damage did confirm the coil near the distal portion of the guide was cut and severed into two separate sections while on the mandril wire.Additionally, a document based investigation evaluation was performed.Cook reviewed the device master record and design history file and found that there are controls in place for this failure.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "how supplied: upon removal from package, inspect and ensure no damage has occurred." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related non-conformances and additional complaints.A review of all associated device history records confirmed no relevant recorded non-conformances.There are no additional complaints on this lot.There is objective evidence the dhr was fully executed.Cook has concluded that there is no evidence that non-conforming product exists in house or in the field.There is no indication the device was manufactured out of specification.The customer has indicated the wire guide was damaged upon opening the package; however, based on the condition of the returned device, it is not clear when the reported damaged occurred.Based on the information provided, the examination of returned product, and the results of the investigation, a definitive cause could not be established.The appropriate internal personnel have been notified.Per the 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 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: 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: 11914623
• MDR Text Key: 262207555
• Report Number: 1820334-2021-01435
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)230129(10)10294422
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: G55723
• Device Catalogue Number: C-PPD-850-IMH
• Device Lot Number: 10294422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1