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

Catalog Number	4252561-02
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: details of complaint (reported issue): incident details: patient required multiple attempts for u/s guided 18g iv for ct with contrast prior to dialysis.I placed an 18g 2 1/2" iv under ultrasound guidance without complications but then noticed the site was bleeding.Upon investigation i found there was a hole or leak at the base of the iv catheter where the catheter meets the colored hub.We were forced to remove the iv.Impact of incident: the patient was unable to get ct scan prior to dialysis, meaning they can no longer use contrast and patient will need a different test to assess for pe.Patient also went through a procedure they found uncomfortable and painful that ended up being futile because the iv had to be removed.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the complaint is considered not confirmed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used and contaminated sample and two (2) photos were submitted to the manufacturer for evaluation.It was noted that the cannula hub and the protective cap were not returned.Attached to the submitted sample was an extension set.Through visual examination of the sample, a cut was observed at the capillary at the catheter hub horn.The cut observed is suspected to be a front cut caused by the reinsertion of the cannula from the front bevel.The cut resembles a v-cut shape.Through visual examination of the photos, one photo is of the peel packaging of the product; however, the article and batch number are not clearly legible.The second photo is of an introcan safety 18g with a red arrow pointing at the capillary near the green hub.A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the reported defect is a result of cannula reinsertion/application error.Therefore, the complaint is considered not confirmed as a manufacturing process issue.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: 17620664
• Report Number: 9610825-2023-00399
• Device Sequence Number: 6118613
• Product Code: FOZ
• UDI-Device Identifier: 04046963318703
• UDI-Public: (01)04046963318703
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020785
• 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,Followup
• Report Date (Section B): 01/18/2024

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: 4252561-02
• Device Lot Number: 22N25G8239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 08/11/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/30/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2023
• 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