MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX ECHO CT W/4IN TUOHY ULTRA 360 SET ANESTHESIA CONDUCTION KIT

Catalog Number 331768

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Anesthesia staff received a box of echo pain block needle sets which were labeled "not for human use" by small pink sticker on the box. This product was sent to the anesthesia department as a sample product. B braun vendor removed the sticker and took the box with her. No patient contact. Manufacturer response for echo pain block needle set, conti echo ct w/4in tuohy ultra 360 set (per site reporter). B. Braun representative notified of event being reported to medsun. Manufacturer rep retrieved our box of 10 echo pain block needle sets. Lot number, 0061671793 retrieved from manufacturer rep to finalize facility report.

• Brand Name: CONTIPLEX ECHO CT W/4IN TUOHY ULTRA 360 SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 8939602
• MDR Text Key: 155815795
• Report Number: 8939602
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019,07/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 331768
• Device Lot Number: 0061671793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage