MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; SET, I.V. FLUID TRANSFER

Model Number 2112550

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).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: it was reported that the valve was misaligned on the transfer set.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One used sample with packaging was returned for evaluation.The sample was reviewed by an engineer and failure for mis-aligned valves was not confirmed and a review of the sw logs indicate a failed leak check test due to improper installation of the transfer set.The sample was leak tested under vacuum per specification with passing results.Based on the evaluation of the sample the reported defect is not confirmed.The defect has been determined to be caused by further processing performed by the customer.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 any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: B.BRAUN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11699142
• MDR Text Key: 249749279
• Report Number: 2523676-2021-00089
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 2112550
• Device Catalogue Number: 2112550
• Device Lot Number: 0061751116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1