MAUDE Adverse Event Report: COOK, INC. FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; KDQ BOTTLE, COLLECTION, VACUUM

Catalog Number C-PPD-850

Device Problem Component(s), broken (1103)

Patient Problem Foreign body, removal of (2365)

Event Date 02/25/2014

Event Type  Injury  

Event Description

A (b)(6) female underwent a lung procedure on (b)(6) 2014.The dr (with an old fuhrman pleural/pneumopericardial drainage set) experienced difficulty when the connection between the connector and the drain got loose - going into the pleural space.The drain had to be removed out of pt with thoracoscopie.Another drain was placed and pt is doing well again.There were no reported adverse effects on the pt due to this occurrence.

Manufacturer Narrative

Event evaluation: still under investigation.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Type of Device: KDQ BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3731650
• MDR Text Key: 4327827
• Report Number: 1820334-2014-00114
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-PPD-850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 55