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

Model Number 412021

Device Problem Air/Gas in Device (4062)

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

Event Date 11/25/2022

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 there were issues with the spikes causing air bubbles to enter into our prismaflex tubings during treatments.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples with packaging were returned for evaluation.The returned samples were visually evaluated per specification with passing results.No hole or imperfections were observed.During the functional testing, no occlusion nor leakage was observed.Based on the evaluation results, the reported defect was not confirmed.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: DISPENSING PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15964928
• MDR Text Key: 308234589
• Report Number: 2523676-2022-00594
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04022495769725
• UDI-Public: (01)04022495769725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412021
• Device Catalogue Number: 412021
• Device Lot Number: 0061837363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1