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

Catalog Number	622275
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Suction Problem (2170)
Health Effect - Clinical Codes	Pneumothorax (2012); Ascites (2596)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the batch history records was performed for the reported lot number, and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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.
Event or Problem Description
As reported by the user facility: detail: when attaching the luer lock to the bottle, it was extremely difficult to connect the tubing and establish suction.As a result, the vacuum somehow released, and when this occurred, air from the bottle was pushed into the patient, causing a pneumothorax that required chest tube placement.After that incident, we performed a paracentesis and again were unable to securely connect the luer lock tubing to achieve suction.We attempted this with multiple bottles and were unsuccessful each time.These were the first two patients for whom we had used these bottles.We tried to establish a connection with empty bottles not attached to the patient and successfully got the suction to release once out of five.

• Brand Name: ACCEL®
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 24568071
• Report Number: 9610825-2026-00135
• Device Sequence Number: 12858128
• Product Code: KDQ
• UDI-Device Identifier: 04046964613371
• UDI-Public: (01)04046964613371(11)250623(17)280623(10)25F23F0000
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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 Catalogue Number: 622275
• Device Lot Number: 25F23F0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown