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

Model Number 622275

Device Problems Degraded (1153); Suction Problem (2170)

Patient Problem Pneumothorax (2012)

Event Date 09/20/2022

Event Type  Injury  

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 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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The complaint samples and two (2) pictures were submitted to the manufacturer for evaluation.Through visual inspection of the photographs and samples, it was observed the grey drain connector is cracked/ripped.A check of the production process shows that such a fault cannot occur in the manufacture of the product.The crack on the grey drain connector could be caused by the combined effect of gamma sterilization and uv radiation, which could have resulted from improper storage.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: 15615968
• MDR Text Key: 301851689
• Report Number: 9610825-2022-00411
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 04046964613371
• UDI-Public: (01)04046964613371
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 622275
• Device Catalogue Number: 622275
• Device Lot Number: 21M11F0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male