MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	NF5140
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, "a brown spot was found on the filter portion of the material.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample and multiple photographs depicting the chamber of the set were provided for evaluation.Visual examination of the photographs noted that foreign material was present on the filter inside of the blood filter housing assembly.The physical sample was evaluated and was noted to have foreign material present in the same location as depicted in the photograph.However, the sample was inadvertently discarded during year-end maintenance performed in our pir investigation lab.All information regarding this complaint was forwarded to our supplier for further investigation.Per the supplier investigation, the exact root cause of the foreign material was unable to be determined.The supplier performed a batch review, and no potential root causes were identified.B.Braun performed a four-year historical review against item nf5140, and it was noted that no other instances of foreign material were reported.Subsequently, a four-year historical search against the purchased part was performed, and no other instances of foreign material have been reported against the purchased part.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 10843636
• Report Number: 2523676-2020-00324
• Device Sequence Number: 11638106
• Product Code: FPA
• UDI-Device Identifier: 04046964187483
• UDI-Public: 04046964187483
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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 Expiration Date: 11/30/2023
• Device Model Number: NF5140
• Device Catalogue Number: NF5140
• Device Lot Number: 0061652899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1