MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG ACCEL EVACUATED DRAINAGE BOTTLE; BOTTLE, COLLECTION, VACUUM

Model Number 622275

Device Problems Backflow (1064); Crack (1135); Noise, Audible (3273)

Patient Problem Pneumothorax (2012)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

Toward end of procedure, last 300 ml the vacuum tube hissed.Crack noted in the tube and the vacutainer was sucking backward into patient's chest causing 10% pneumothorax.Fda safety report id# (b)(4).

• Brand Name: ACCEL EVACUATED DRAINAGE BOTTLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 15503266
• MDR Text Key: 300912698
• Report Number: MW5112328
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 622275
• Device Catalogue Number: 622275
• Device Lot Number: 21M11F0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male