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	06/01/2022
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 japan."product leakage." "the user noticed a leakage from the connection when the user pierced the patient, connected an extension tube, flushed it with physiological saline to check for reverse blood.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Samples evaluation: received the following samples: - 3 used and contaminated capillary hub of introcan safety 3 pur 22g 0.9x25mm-ap without packaging.Returned together with the used samples are extension set and a syringe.- 75 unused samples in original packaging.Lot number printed on returned peel pack are 21l07g8374 and material# 4251128-03.Visual inspection: inspected the returned samples and found 14 pcs with damage or dent at catheter luer.Air tightness test: the 14 pcs were subjected to air tightness leakage test at 300 kpa / 30 seconds in water according to test method.Result: no leakage observed.Liquid tightness using terumo extension tube set: the 14 pcs were subjected to liquid tightness using terumo extension tube set.Result: no leakage observed.Liquid tightness using top extension tube set: the 14 pcs were subjected to liquid tightness using top extension tube set.Result: no leakage observed.Root cause analysis: the possible cause of the dent luer could be due to slightly bent or slant septum opener pin during the assembly of catheter hub to cannula hub.During simulation, the defect was able to reproduce.Another possible cause is bigger opening of septum opener pin towards the catheter hub luer and during simulation, the defect was able to reproduce.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: 14958208
• Report Number: 9610825-2022-00249
• Device Sequence Number: 6915018
• 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): 12/09/2022

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: 06/13/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 12/09/2022
• 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