MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER, INTRAVASCULAR, THE

Catalog Number	4251601-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: brief inquiry description the passive safety clip did not engage when the needle was removed from the catheter.Detailed inquiry description the nurse inserted the iv successfully and when the needle was removed, the passive safety clip did not engage and the nurse was stuck when putting the needle down.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Seven (7) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, flashback of blood in the flashback chamber was observed in all photos.The safety clip dislodged and was located near the cannula crimp area and not covering the cannula tip.The cannula was slightly bent.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.This product is assembled on an automated assembly machine equipped with 100% vision system and test stations.The process cars for the complaint batch show no abnormality.The stamping ipqc data for the clip batches use din the complaint sample showed no deviation and all measurements were within the specification.Products are subjected to in-process and final control tests.No damage or failed clip function related for the reported batch number.Based on the photos, a root cause could not be identified.The batch records show no abnormalities; therefore the complaint is considered not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER, INTRAVASCULAR, THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19639069
• Report Number: 9610825-2024-00542
• Device Sequence Number: 18283452
• Product Code: FOZ
• UDI-Device Identifier: 04046963166274
• UDI-Public: (01)04046963166274
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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 Catalogue Number: 4251601-02
• Device Lot Number: 24A11G8361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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