MAUDE Adverse Event Report: B. BRAUN MEDICAL INC B.BRAUN; CONTAINER, IV

Model Number	S9902-10
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Air Embolism (1697); Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.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: air filled the iv tubing toward the patient instead of pulling out blood into the bottle.Air in tubing did not reach the patient.It was immediately clamped.The patient was not harmed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).No samples were returned for evaluation.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.The customer reported air in line during blood collection.This is an off-label use of the product.The label on the container and the ifu both state "not a blood collection device".Additionally the ifu indicates to "check the bottle for cracks or other damage" as cracks could compromise vacuum functionality.

• Brand Name: B.BRAUN
• Common Device Name: CONTAINER, IV
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 2525 mcgaw avenue; irvine CA 92614 5895
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 2525 mcgaw avenue; irvine CA 92614 5895
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12826787
• Report Number: 2021236-2021-00014
• Device Sequence Number: 1481653
• Product Code: KPE
• UDI-Device Identifier: 04046964187797
• UDI-Public: (01)04046964187797
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 02/18/2022

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: 07/31/2023
• Device Model Number: S9902-10
• Device Catalogue Number: S9900-10
• Device Lot Number: J8J453
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male