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

Model Number 622299

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

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 Description

As reported by the user facility: event 1: detailed inquiry description: after connecting the accel bottles the nurses realized that the vacuum had been lost so no suction occurred.No injury reported.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).No sample was received and thus a further evaluation and investigation of the complaint is not possible.As no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as 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®
• Type of Device: 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: 16875371
• MDR Text Key: 314623682
• Report Number: 9610825-2023-00192
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 04046955323494
• UDI-Public: (01)04046955323494
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 622299
• Device Catalogue Number: 622299
• Device Lot Number: 22M29F0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1