MAUDE Adverse Event Report: INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL LLC TRACHEOESOPHAGEAL PUNCTURE SET; TRAY, SURGICAL KIT

Lot Number 0000099350

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2019

Event Type  Injury  

Event Description

An (b)(6) male.During procedure a piece of the plastic sheath broke off inside the patient.Piece was successfully retrieved and removed from the patient.A second sheath was attempted and also started to tear, but did not break off.Second sheath removed.Fda safety report id # (b)(4).

• Brand Name: TRACHEOESOPHAGEAL PUNCTURE SET
• Type of Device: TRAY, SURGICAL KIT
• Manufacturer (Section D): INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL LLC
• MDR Report Key: 8611948
• MDR Text Key: 145263961
• Report Number: MW5086630
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Lot Number: 0000099350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 61