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

Catalog Number 332103

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

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: the customer opened a tray and discovered fluid droplets within the syringe.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400430110.No sample was received for further evaluation.Due to previous complaints for the same issue, our internal document was updated with pictures and instructions to clarify the handling of the plunger tips.Additionally, pictures of unacceptable syringes were also added.This document became effective on 2019-04-26.Since this lot was produced before this change, no further actions will be taken at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.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.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: CONTIPLEX
• Type of Device: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8612047
• MDR Text Key: 145130872
• Report Number: 2523676-2019-00062
• Device Sequence Number: 1
• Product Code: OGJ
• UDI-Device Identifier: 04046964177422
• UDI-Public: 04046964177422
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 332103
• Device Lot Number: 0061638374
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1