MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B BRAUN FILTERED EXTENSION SET 0.2; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 00VL821573

Device Problems Crack (1135); Fluid/Blood Leak (1250); Noise, Audible (3273)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

Tpn clear filter port cracked.When i connected the lipids tubing/filter to tpn tubing/filter, i heard a slight crack (i applied normal pressure when screwing the tubing to the port).Everything worked for about an hour then that tpn/filter port started leaking.Lipids were connected to this port, so the lipids leaked everywhere.To tests this, i connected a flush to that broken port and it literally leaked everywhere.This is the third time the tubing has been broken.Given to floor clinician.Fda safety report id# (b)(4).

• Brand Name: B BRAUN FILTERED EXTENSION SET 0.2
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 14408887
• MDR Text Key: 291852618
• Report Number: MW5109713
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 00VL821573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White