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

Model Number	622299
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (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 3: detailed inquiry description: the bottles don't have vacuum.No injury reported.
Additional Manufacturer Narrative
Event 3 this report has been identified as b.Braun medical internal report number (b)(6).One used sample and 23 unused unopened samples were returned for evaluation.Ten of the samples were then subjected a negative pressure (vacuum) test.The results of the test noted that all tested samples were within specification.Based on the investigation, the samples are within manufacturing specification; therefore, the complaint is considered not confirmed.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 16814440
• Report Number: 9610825-2023-00180
• Device Sequence Number: 17576161
• Product Code: KDQ
• UDI-Device Identifier: 04046955323494
• UDI-Public: (01)04046955323494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/26/2023

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: 12/19/2025
• Device Model Number: 622299
• Device Catalogue Number: 622299
• Device Lot Number: 22N19F0000
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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