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

Model Number 622275

Device Problems Degraded (1153); Suction Problem (2170)

Patient Problem Pneumothorax (2012)

Event Date 09/22/2022

Event Type  Injury  

Event Description

This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility: event description: provider was performing a centesis and when bottle had about 300ml left to fill a hissing sound was heard and air began to fill patient lung.The grey rubber top was cracked and broke thus breaking the vacumm.

• Brand Name: ACCEL®
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; deli külhatar u. 2 - 4; gyöngyös, 3200 ; HU 3200
• MDR Report Key: 15616054
• MDR Text Key: 301844145
• Report Number: 3006332832-2022-00002
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 04046964613371
• UDI-Public: (01)04046964613371
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2022
• Device Age: 1 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male