MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Model Number	352640
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: it was reported that the set came apart at distal port that connects to iv catheter, and blood leaked.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) photograph depicting a soaked clothes/jacket was provided for evaluation.A visual evaluation was performed on photograph and it was noted the jacket on floor per event description was soaked from the leak.However, it is difficult to determine the source of leakage from photo.Based on the evaluation results, the root cause of the reported incident was unable to be determined via the photo.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: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12811055
• Report Number: 2523676-2021-00381
• Device Sequence Number: 4757207
• Product Code: FPA
• UDI-Device Identifier: 04046955594696
• UDI-Public: (01)04046955594696
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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 Model Number: 352640
• Device Catalogue Number: 352640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 67 YR
• Patient Sex: Female