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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
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 "air came in from the connection." " there was a report that air was mixed in from the infusion connection part.The sample will be sent with the top extension tube connected.The same event has been reported before (lot21g04g8373 / cc400556698).This time, we will send samples for 1 used and 2 unopened, a total 3 pcs.Please also investigate unopened products.The patient has no infection / health hazard to patien: none.Sample: available, will be shipped later.Batch: 21g04g8373.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Sample evaluation: received 1 used and contaminated capillary hub of introcan safety 3 pur 18g 1.3x32mm-ap without packaging.Cannula hub and protective cap were not returned for investigation.Attached with the used sample is an extension set, presumably used together with the introcan safety.Also being returned are 2 unused samples in original packaging.Lot number printed on peel pack are 21g04g8373 and material# 4251128-03.Visual inspection: result: observed 1 pc of used sample exhibits damage on the catheter hub luer while 2 pcs of unused sample no damage observed.Leakage test: 1 pcs sample with damage on the catheter hub luer were tested for air tightness leakage test according to test method.Result: 1 pcs sample passed the test.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 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: 14888640
• Report Number: 9610825-2022-00250
• Device Sequence Number: 12333054
• Product Code: DQR
• UDI-Device Identifier: 04046964398858
• UDI-Public: (01)04046964398858(17)260701(10)21G04G8373
• 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: 4251131-03
• Device Lot Number: 21G04G8373
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 07/01/2022
• 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