MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT; SET, ADMINISTRATION, INTRA

Model Number 363430

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/22/2021

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: the patient did not receive the proper treatment which is the propofol sedation required.Luckily it did not cause any complication in the patient condition.On the other hand the patient lost blood from the leaking port.This was an unnecessary blood lost.Since this is an opened medium, this puts the patient at risk for infection.According to the customer, the product leaked from the part of insertion of the needle causing injuries to the patient.The central line blood backing up and leaking through a primary line port.The primary line had ns running and the port at which blood leaked had propofol line attached to it.The port had a hole.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Further investigation of the complaint is not possible.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: INFUSOMAT
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11840358
• MDR Text Key: 251151218
• Report Number: 2523676-2021-00120
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294679
• UDI-Public: 04046964294679
• Combination Product (y/n): N
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 363430
• Device Catalogue Number: 363430
• Device Lot Number: 0061732949
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1