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	05/20/2022
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)(4)."product leakage." after puncturing the patient, an extension tube was connected to it and flushed with physiological saline.At that time, when the user confirmed the reverse blood, he noticed a leak from the connection part.The same event also happened a month ago.There are no used actual products and we will send 24 of the same lot products, so please investigate.The patient has no infection / health hazard to patient: none / sample: available, will be shipped later./ batch: 21n08g8371.".
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 2 used and contaminated capillary hub of introcan safety 3 pur 22g 0.9x25mm-ap without packaging together with 2 extension tubes.Cannula hub and protective cap were not returned for investigation.Visual inspection: 2pcs samples observed damage at the catheter hub luer.Air tightness test: 2pcs samples were subjected to air tightness leakage test at 300kpa/30s (3bar/30s).Results: 2pcs samples failed the test.Liquid tightness test: 2 pcs were subjected to liquid tightness test 300kpa/30s (3bar/30s).Result: 2pcs samples passed the test.Extension tube set verification: 2 pcs samples which exhibits catheter hub luer damage were tested for liquid tightness test 300kpa/30s (3bar/30s) by using returned extension tube set.Results: 2 pcs tested - 2 pcs failed.Root cause analysis: the possible cause of the dent luer could be due to slightly bent or slanted 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.Corrections/containment measure: daily checking for valve opener pin condition and record in process card.Started on 2022-05-12.Capa has been initiated to address this defect.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: 14578296
• Report Number: 9610825-2022-00217
• Device Sequence Number: 17434428
• Product Code: DQR
• UDI-Device Identifier: 04046964399091
• UDI-Public: (01)04046964399091(17)261201(10)21N08G8371
• 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: 21N08G8371
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• 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