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	05/06/2022
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." "the user connected to an extension tube to flush the contrast agent and started administration.After that, it leaked from the connection part with wrinkles.It was connected to top's x1.5-fl150ct.The user connected it to the syringe and checked it, but also confirmed the leak.We will also collect and send all unused items of the same lot as the two actual items.The patient has no infection / health hazard to patient: none / 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).Samples evaluation: received the following samples: - 1 used and contaminated capillary hub of introcan safety 3 pur 22g 0.9x25mm-ap in opened packaging - 82 pieces in original packaging.Lot number printed on returned peel pack are 21l07g8374 and material# 4251128-03.Visual inspection: visually inspected on the returned samples for damages.Result: 12pcs observed damaged at catheter hub luer.Air tightness test: the 12 pcs were subjected to air tightness leakage test at 300 kpa / 30 seconds in water according to test method.Result: 1pc sample failed the test.Liquid tightness test: the 1pc samples which failed the air tightness leakage test was tested for liquid tightness test 300kpa/30s (3bar/30s).Result: 1 pc sample passed.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: 14577953
• Report Number: 9610825-2022-00212
• Device Sequence Number: 6169771
• 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): 08/23/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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