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

Catalog Number	NF5140
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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: it was reported that during spiking, prior to use on patient, the product leaked.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used set spiked into two sodium chloride iv bags were returned for evaluation.In addition a video was provided by the facility.The set was leak tested per specification and leakage was observed on the proximal end of the blood filter at the bonded joint.Although the reported defect was confirmed, the exact root cause 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.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.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: 9131107
• Report Number: 9614279-2019-00170
• Device Sequence Number: 2503263
• Product Code: FPA
• UDI-Device Identifier: 04046964187483
• UDI-Public: 04046964187483
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 10/31/2019

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: 05/31/2024
• Device Catalogue Number: NF5140
• Device Lot Number: 0061681745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1