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

Model Number	473447
Medical Device Problem Code	Fluid/Blood Leak (1250)
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, "the customer is complaining of extension set leakage of fluid and blood.In some instances at both the male luer connector, and others at the junction of the ultra-site connection to the extension set.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).(b)(6) unopened samples from 3 sealed cases were returned for evaluation.In addition, two (2) photos were provided.Upon visual inspection of the photos, no defects were detected.A random sampling of (b)(6)returned units ((b)(6)from each case) was visually evaluated with no defects noted.The samples were then leak tested per specification with passing results, as leakage was not detected from any of the samples.Based on the data from our evaluation, the reported defect was unable to be observed or replicated with the returned samples.The exact nature of the reported leakage was unable to be determined at this time.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: ULTRASITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon boulevard; allentown PA 18109
• MDR Report Key: 10699125
• Report Number: 2523676-2020-00293
• Device Sequence Number: 14883818
• Product Code: FPA
• UDI-Device Identifier: 04046964185342
• UDI-Public: 04046964185342
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• 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): 11/24/2020

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 Expiration Date: 06/30/2025
• Device Model Number: 473447
• Device Catalogue Number: 473447
• Device Lot Number: 0061739412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1