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

Model Number	456030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: customer reports that the tubing was "split" or "sliced" open, and that when the nurse hooked it up to the patient, the patient's blood "poured out".The nurse immediately disconnected the tubing.Minimal blood loss reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used extension set without packaging was returned in connection with this complaint.Visual examination noted a cut in the tubing in the direction of the axis and approximately 170mm behind the discofix.Upon visual examination, it was determined that the tubing had been cut off by the sealing tool during the packaging process.The batch record and our discrepancy management system database could not be reviewed as a lot number was not provided.In response to this incident, a visual information documenthas been created to sensitize relevant employees regaridng this failure.Additional, an information board has been installed on the production floow with information and examples of failure modes.Further, instructions concerning the correct handling of the process during packaging were reviewd with revevant employees.In response to similar reports of this nature, b.Braun has initiated a corrective action and preventative action (capa) which provides for root cause analysis and corrective action.We will maintain this report for further references, and continue to monitor other reports for similar occurrences.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9176306
• Report Number: 2523676-2019-00174
• Device Sequence Number: 11733619
• Product Code: FPA
• UDI-Device Identifier: 04022495770066
• UDI-Public: 04022495770066
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: 456030
• Device Catalogue Number: 456030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1