MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; NERVE BLOCK TRAY (KIT)

Model Number 332100

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

Per medwatch number: (b)(4).Event description: 5cc plastic syringe was found to contain what appeared to be a black particle of stopper.The presence of this particle was observed by physician prior to administration, when triamcinolone acetonide injectable suspension was drawn into 5cc plastic syringe.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Based on the data from the investigation we are unable to determine the root cause of the reported incident.  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.  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: B.BRAUN
• Type of Device: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10132696
• MDR Text Key: 194537640
• Report Number: 2523676-2020-00156
• Device Sequence Number: 1
• Product Code: OGJ
• UDI-Device Identifier: 04046964177408
• UDI-Public: 04046964177408
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 332100
• Device Catalogue Number: 332100
• Device Lot Number: 0061707901
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1