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 Date 03/27/2019

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: event 2: customer reported that during preparation, transfer sets were found to have skewed valves.No injuries were reported.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Three (3) used transfer sets with packaging were returned for evaluation.Also, a picture was submitted that depicts the defect.Visual examination of the three sets notes that some of the valves are misaligned.Software logs were reviewed by the sme (subject matter expert) and confirm a valve dance failure.This type of failure causes the valves to rotate fully to a closed position and give the appearance of a skewed valve when the set is removed and visually inspected from the underside.This type of observation is not a transfer set failure, but an attribute of the system.The picture submitted by the customer reflects the sample for the misaligned valves.The defect of misaligned valves is not confirmed since this is not a set failure but a software issue that is already known.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 8515726
• MDR Text Key: 141981792
• Report Number: 2523676-2019-00023
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 2112550
• Device Lot Number: 0061645612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Distributor Facility Aware Date: 03/27/2019
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1