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)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.The patient went to the ed via ambulance for hypoxia.Patient received oxygen treatment and fully recovered.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) container was received from lot j8k467 (s9900-10) for evaluation.The outer closure had been removed and the stopper had been punctured with at least 5ml solution inside the bottle.Due to the condition of the unit it cannot be tested.Visual evaluation showed no defects.A total of seven (7) cases, with six (6) unused units per case, plus two (2) separate unused units were received, for a total of 44 unused units.One (1) of the forty-four (44) unused glass containers was found with a low vacuum (24.94 in.Hg).The specification is a minimum of 25.5 in.Hg minimum (648 mm).Further investigation determined the low vacuum was due to a crack.Visual inspection forty-three (43) unused samples showed no cracks or damaged.A review of our discrepancy management system database found no related or similar discrepancies during the production of the batch.The customer reported air in line during blood collection.This is an off-label use of the product.The used returned unit exhibited a crack which can cause loss of vacuum.The loss of vacuum is confirmed; however, it is not confirmed that the air in line is due to vacuum loss, as the facility was using the container in an off-label manner and this also may have contributed to the event (technique used for blood collection).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: 12826785
• Report Number: 2021236-2021-00013
• Device Sequence Number: 1481652
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: S9902-10
• Device Catalogue Number: S9900-10
• Device Lot Number: J8K467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• 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: 08/28/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male