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

Model Number	490438
Medical Device Problem Code	Leak/Splash (1354)
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 blood set leaked from the seal of the hand pump.Tubing was changed during the case.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used samples with no packaging was received for evaluation.A functional leak test was performed on the sample and it was noted that the cap of the hand pump was the source of the leak.A visual evaluation under magnification showed that the leak was due to no evidence of solvent along the cap of the hand pump.Retains for batch 0061762126 passed internal testing.Although the reported defect was confirmed on the sample returned, the exact root cause could not be determined.Similar complaints reporting defect of this nature initiating a project to address the concerns of this defect.A ttp (technology transfer plan) was approved on 10 february 2021.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12422230
• Report Number: 2523676-2021-00298
• Device Sequence Number: 6079000
• Product Code: FPA
• UDI-Device Identifier: 04046964833441
• UDI-Public: 04046964833441
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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): 10/29/2021

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: 12/31/2023
• Device Model Number: 490438
• Device Catalogue Number: 490438
• Device Lot Number: 0061762126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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