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	05/19/2022
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 (b)(6)."product leakage." "during priming of infusion preparation in the chemotherapeutic room, a liquid leak occurred from the jms infusion set connection.This is the second case at this department, and lot is different from the last time.About 5 same cases have occurred at this facility.The patient has no infection / health hazard to patient: none / sample: available, will be shipped later./ batch: 21h29g8371.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Device history record (dhr): reviewed the device history record for batch number 21h29g8371 and there were no defects encountered during in process and final control inspection.Sample evaluation: received 1 used and contaminated introcan safety 3 pur 22g 0.9x25mm-ap in an opened packaging.Lot number printed on returned peel pack is 21h29g8371 and material# 4251128-03.Visual inspection: visual inspection from the 1 pc returned sample, no damage or dent at catheter luer.Air tightness test: sample was subjected to air tightness test at 300 kpa / 30 sec under water.Result: no leakage observed.Conclusion: no damages and no leakage were observed on the returned sample.Complaint is not 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: 14578112
• Report Number: 9610825-2022-00216
• Device Sequence Number: 17412619
• Product Code: DQR
• UDI-Device Identifier: 04046964399091
• UDI-Public: (01)04046964399091(17)260801(10)21H29G8371
• 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: 21H29G8371
• 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
• Date Device Manufactured: 08/29/2021
• 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