MAUDE Adverse Event Report: COVIDIEN UNKNOWN CARDIO THORACIC; TROCAR

Model Number UNKNOWN CARDIO THORACIC

Device Problem Component Missing (2306)

Patient Problem Pneumothorax (2012)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The incident device has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that there was an incident where a patient was in the crisis unit of the er and the physician went to grab a trocar and there was no catheter inside the sealed tube.This occurred 3 times, according to the doctor, until she found a tube with a catheter as expected.Per additional information received from the customer on (b)(6) 2020, the delay in care was brief and it seemed it was within a minute of delay, as this was a critical patient in the er.The customer further reported that there was no patient harm/injury and no medical intervention as a result of this incident.

Manufacturer Narrative

Additional information: a device history record (dhr) review could not be performed because a lot number could not be provided by the customer.There were no physical samples or pictures submitted with this complaint report.The complaint will be reopened if a sample is received.The reported condition is unable to be confirmed.A formal investigation was open in order to determine the root cause and implement the appropriate corrective and preventative action (capa).A production notification was performed to all personnel to ensure that they are aware of the condition reported.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN CARDIO THORACIC
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9948233
• MDR Text Key: 187199450
• Report Number: 9612030-2020-02446
• Device Sequence Number: 1
• Product Code: DRC
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN CARDIO THORACIC
• Device Catalogue Number: UNKNOWN CARDIO THORACIC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other