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

Model Number	4251601-020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)."product leakage." "after inserting the product to the patient, when it was connected to the extension tube and tried the medical liquid to flow, the leakage from the connection part was confirmed.In addition, syringe was connected to the product and tried to be pulled, only air was pulled.No infection to the patient/ no health hazard to the patient/sample available/ batch 21l07g8374".
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Sample evaluation: received 1 piece of used and contaminated capillary hub of an introcan safety 3 pur 22g 0.9x25mm-ap without packaging.Cannula hub and protective cap were not being returned for investigation.Visual inspection: result: 1pc used observed damaged at catheter hub luer.Air tightness test: the 1 pc was subjected to air tightness leakage test at 300 kpa / 30 seconds in water according to test method.Result: no leakage was observed.Root cause analysis: the possible cause of the dent luer could be due to slight bend or slant septum opener pin during the assembly of catheter hub to cannula hub.During simulation, the defect was able to be reproduced.Another possible cause is bigger opening of septum opener pin towards the catheter hub luer and during simulation, the defect was able to be reproduced.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: 14578056
• Report Number: 9610825-2022-00213
• Device Sequence Number: 5064824
• Product Code: DQR
• UDI-Device Identifier: 04046964399091
• UDI-Public: (01)04046964399091(17)261001(10)21L07G8374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/24/2022

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 Model Number: 4251601-020
• Device Catalogue Number: 4251128-03
• Device Lot Number: 21L07G8374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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