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

Model Number	622275
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 4(b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 4: detailed inquiry description: nurses realized that the bottles had no suction after connecting the line.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 4: no sample or photos were submitted to the manufacturer for evaluation.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non- conformances were noted during the in process or final product inspection.The complaint is considered not confirmed.If the device does become available, the complaint will be reopened for further evaluation.

• 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
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; deli külhatar u. 2 - 4; gyöngyös, 3200 ; HU 3200
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16875402
• Report Number: 9610825-2023-00199
• Device Sequence Number: 12219979
• Product Code: KDQ
• UDI-Device Identifier: 04046964613371
• UDI-Public: (01)04046964613371
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2025
• Device Model Number: 622275
• Device Catalogue Number: 622275
• Device Lot Number: 22M11F0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown