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

Model Number	4252500-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: "one of our medics placed an iv on a patient this morning while i was in the room, she had no problem placing it.The iv site was in the antecubital and the patient's arm was completely straight.The patient was not moving.The medic did not meet any resistance when placing the iv.When she went to flush the line with normal saline (about 3 mls) she noticed a lot of saline and blood coming out around the insertion site.She called me over to look at it.I asked her if it was the insertion site or the catheter leaking.She pulled the catheter back a bit so the hub (yellow part of iv) wasn't directly up against the skin and flushed again.This time we both could clearly see it was coming out between the hub and catheter.I told her to pull the iv out and place a new one.When she did that only the hub ( yellow part) was in her hand.The actual catheter portion was still in the patient's vein.It was out far enough that she was able to pull the catheter out with her fingers.".
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).Two photos were provided for further evaluation.Visual evaluation confirms that the capillary was used as it was filled with blood.The capillary was also detached from the capillary hub.The second photo confirmed the item and batch number.As no sample was provided for evaluation, the exact root was unable to be determined.The actual defective device is a valuable tool in investigating the cause of this incident.A review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.Additionally, the manufacturer evaluated their production processes and were unable to identify a process that would create this defect.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: 15804596
• Report Number: 9610825-2022-00474
• Device Sequence Number: 5528269
• Product Code: FOZ
• UDI-Device Identifier: 04046963165963
• UDI-Public: (01)04046963165963
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/27/2022

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: 4252500-02
• Device Catalogue Number: 4252500-02
• Device Lot Number: 22E15G8921
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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