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

Catalog Number 332100

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, it was confirmed that the batch number was unknown and the sample was not available for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: event 1: complaint: customer stated the syringes in the peripheral nerve block support tray had "condensation" in them.They appeared "cloudy".No injury reported.

• Brand Name: B.BRAUN
• Type of Device: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 8148467
• MDR Text Key: 130329578
• Report Number: 2523676-2018-00100
• Device Sequence Number: 1
• Product Code: OGJ
• UDI-Device Identifier: 04046964177408
• UDI-Public: 04046964177408
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 332100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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