MAUDE Adverse Event Report: BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Model Number	477005
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 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: it was reported that the tubing leaks at the connection port site.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) contaminated sample with open packaging was returned for investigation.Visual examination and functional leak test, confirmed a crack on the backcheck valve located near the patient connector.Based on the evaluation of the sample the reported defect is confirmed.The most likely potential cause is that the defect originated from excessive force being placed on the valve during use.While an exact root cause cannot be determined, review of the complaint sample 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.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: BLOOD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12036921
• Report Number: 2523676-2021-00187
• Device Sequence Number: 1622195
• Product Code: FPA
• UDI-Device Identifier: 04046955202799
• UDI-Public: 04046955202799
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K140311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 477005
• Device Catalogue Number: 477005
• Device Lot Number: 0061762112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1