MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Model Number 456020

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/10/2022

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: details of complaint (reported issue): stopcock leaking onto pillow (lumen that was infusing pressor and sedation medications) and patient blood pressure dropped with interruption of infusion.Pt repositioned in bed.Blood pressure (down arrow) thereafter, initially thought related to repositioning.Write increased pressor medication dose with no affect.On further inspection, stopcock leaking onto pillow (lumen that was infusing pressor and sedation medication).Pt was on high dose pressors - bp dropped to ~79/41 (50) with interruption of infusion.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Three (3) samples were provided for evaluation.The samples were subject to a visual evaluation.Two of the three sample passed the visual evaluation.The third sample was visual evaluated and failed.Upon testing the sample per specification, a leak/crack was observed on the top port of the discofix.A visual investigation of the sample was performed by the manufacturing site it was detected a crack in the lli-cone.While an exact root cause cannot be determined, review of the complaint samples and manufacturing records suggests that the defect did not originate from a failure in the manufacturing processes.Based on these findings the most likely potential cause is that the defect originated from excessive force being placed on the valve during use.Please note a probable root cause for cracks in the lli-cone could be high tensions in combination with disinfectants and / or certain drug ingredients (oil, alcohol, lipids etc.).Because of this, we assume of a problem during the application process.Retained units were evaluated and passed the internal testing.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: DISCOFIX®
• Type of Device: ACCESSORIES, CATHETER
• 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: 15503676
• MDR Text Key: 306273880
• Report Number: 2523676-2022-00485
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: (01)04046964996962
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 456020
• Device Catalogue Number: 456020
• Device Lot Number: 21F10D9046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2021
• 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