MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; I.V. SAFETY CATHETER

Model Number	4251601-020
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4): " air in the syringe." "the patient was on noradrenaline infusion running at approx.10mls/hr, the intended fluid volume was approx.30mls.The patients bp was dropping so we went up on the infusion rate to 15mls/hr then to 20mls/hr but the patient's bp remained unchanged.The nurse checked the patients cvc to make sure there was no kink in the line- there wasn't.She checked the pump, opened the door and could see approx.20mls of air in the syringe so the syringe looked half filled when lying flat.The patients bp recovered when the norad infusion was changed quickly to the 2nd norad infusion that was on standby.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Evidence of disposal: no sample available due to sample was discarded by the hospital and no photos provided for evaluation.This complaint shall be taken to the knowledge and filed for statistical purpose.However, should sample become available and being returned, complaint will be re-opened and re- investigated accordingly.Root cause analysis: investigation was conducted to identify the potential stations at the machines which may have contact with the catheter hub luer.By ruling out all the possibilities, the only possible chance to induce this defect is in machine at assembly catheter hub into cannula hub station if the septum opener pin is bent or bigger opening of the septum opener pin.Correction: daily checking for valve opener pin condition and to record in process card.Started: 2022-05-12.Additional containment action to refer to capa.This complaint is confirmed.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14653151
• Report Number: 9610825-2022-00220
• Device Sequence Number: 4712085
• Product Code: DQR
• UDI-Device Identifier: 04046964399091
• UDI-Public: (01)04046964399091(17)261001(10)21L07G8374
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2022
• 2 Devices were Involved in the Event: 1 2

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: 4251601-020
• Device Catalogue Number: 4251128-03
• Device Lot Number: 21L07G8374
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 12/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown