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

Catalog Number	4252520-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
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
An unannounced sample arrived that was originally for complaint pir (b)(4).As reported by the user facility: brief inquiry description: problems with catheters sheared when coming out of package.Detailed inquiry description: crt and i (emily from vascular access) were using 22g 1.75 inch catheters to place ultrasound ivs in multiple patients during the morning of (b)(6) 2021.On multiple occasions, including the most noticeable incident with the patient stated in the report, the catheter wouldn't advance from the needle and was causing pain to the patients upon insertion.So, we removed it and found the catheter to be sheared.This happened 3 times using the 22g 1.75 inch catheters on multiple patients.I saved the package but not he actual catheter due to it being a biohazard.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A total of three (3) samples from lot # 23k10g8241 was submitted to the manufacturer for evaluation.No samples were received from lot # 23l16g8241.Through visual examination of the returned samples, no defects or damages were observed.The samples were then subjected to penetration force and gliding force test; all of the samples passed specification.A review of the device history record (dhr) was performed for the reported lot numbers and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the samples were within specification and no defects were observed.The reported defect could not be 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.Correction: initial information noted that date of occurance was on (b)(6) 2021.The actual date of occurance was on (b)(6) 2024.

• 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: 19570080
• Report Number: 9610825-2024-00524
• Device Sequence Number: 6305970
• Product Code: FOZ
• UDI-Device Identifier: 04046963318178
• UDI-Public: (01)04046963318178
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 4252520-02
• Device Lot Number: 23K10G8241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2023
• 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