MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ANESTHESIA SUPPORT TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 332114

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for evaluation and 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: end user stated that her staff is noticing either increased moisture or excess lubricant on the inside of the syringes.It was stated that it seems like its lubricant.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.Without the actual device, a thorough investigation could not be performed.A 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 a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: ANESTHESIA SUPPORT TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7859870
• MDR Text Key: 119932436
• Report Number: 2523676-2018-00074
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046964177507
• UDI-Public: 04046964177507
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 332114
• Device Lot Number: 0061624161
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1