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

Model Number	622275
Medical Device Problem Codes	Degraded (1153); Suction Problem (2170)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem 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®
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; deli külhatar u. 2 - 4; gyöngyös, 3200 ; HU 3200
• MDR Report Key: 15616054
• Report Number: 3006332832-2022-00002
• Device Sequence Number: 8035523
• Product Code: KDQ
• UDI-Device Identifier: 04046964613371
• UDI-Public: (01)04046964613371
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male