MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; I.V. FLUID TRANSFER NEP-SYSTEM/DEVICE, PHARMACY CO

Catalog Number 2112550

Device Problem Failure to Align (2522)

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: customer reported that during preparation, transfer sets were found to have skewed valves.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun inc.Internal report # (b)(4).One (1) used transfer set with packaging was returned by the customer for evaluation.Visual examination of the set noted that the valves are misaligned.This type of observation is not a transfer set failure but is most likely due to improper set up on the pump module.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: B.BRAUN
• Type of Device: I.V. FLUID TRANSFER NEP-SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8594992
• MDR Text Key: 144572714
• Report Number: 2523676-2019-00035
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04046964656101
• UDI-Public: 04046964656101
• Combination Product (y/n): N
• PMA/PMN Number: K151423
• 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: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 2112550
• Device Lot Number: 0061649014
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/27/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1