MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4251129-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reproted by the user facility: brief inquiry description "introcan 3 safety mechanism failed to cover the end of the needle." detailed inquiry description sharing for awareness that the emergency dept.Here at smh had another iv catheter that the safety mechanism failed to engage.See riskmaster below."failure bbraun 20 guage iv catheter safety feature again did not engage at end of needle.The safety feature engaged about half way down the needle and left the tip of the needle exposed after removed.This happened with this pt as well as 1 other patient earlier today.".
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).Three (3) photos were submitted to the manufacturer for evaluation.Through visual examination, it was observed that the safety clip was not covering the cannula tip but was located near the cannula hub.The actual malfunction of the safety clip and the cannula surface could not be identified from these photos.The sample within the photos is not within specification; the reported defect is confirmed.This product is assembled on an automated assembly machines equipped with 100% vision system and test stations.Along the machines, there is 100% on the clip condition, clip position, clip hole, crimp width and crimp length.Defective parts would be detected and be rejected automatically by the machine.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in -time and would be mitigated immediately.As the batch is unknown, the process cards could not be reviewed.Based on the investigation, while the defect was observed from the provided photos, an exact root cause could not be determined.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® 3
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20466433
• Report Number: 9610825-2024-00796
• Device Sequence Number: 12571694
• Product Code: FOZ
• UDI-Device Identifier: 04046964014031
• UDI-Public: (01)04046964014031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111236
• 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): 11/01/2024

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: 4251129-02
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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