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

Catalog Number	332100
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
As reported by the user facility: event 2: 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
• Common Device Name: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8148480
• Report Number: 2523676-2018-00101
• Device Sequence Number: 1459802
• Product Code: OGJ
• UDI-Device Identifier: 04046964177408
• UDI-Public: 04046964177408
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 332100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1