MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY ® 2; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4232012-02
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 reported by the user facility: issue: "the iv cath has some resistance when sliding the catheter end out from the needle into the patient.It has a dragging feel to it, where it is supposed to be smooth.The nurses started noticing this this week.It happens in the 18ga needle catheter." & "reported to me that she used an 18 gauge iv to flush a wound.She removed the needle from the catheter and met resistance.When she was able to remove the needle fully the clip that should be on the end was stuck halfway up the needle and the needle tip was exposed.No one was harmed.Lot 22g21g827a upon further inspection of catheters, there are 2 18-gauge lots that have more than normal resistance when separating the needle from the catheter.These were removed from the department, placed in the manager's office.The lot currently in the er is functioning appropriately only 18 gauge found to have issues.The other lot with resistance is 22m04g8271.".
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).Twelve (12) samples and three (3) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, one of the photos showed the septum opener and safety clip were at the middle of the cannula and not covering the cannula tip.It was observed that the septum was attached to the cannula and was dislodged from the catheter hub.The other two photos were of the peel pack for the product.The samples were subjected to functional testing: lot # 22g21g827a - two pieces failed the withdrawal and drag force test.Six pieces failed the drag force test.The samples that failed the test are not within specification; the reported defect is confirmed.A review of the device history record (dhr) was performed for the reported lot numbers and no abnormalities or nonconformances were noted during the in process or final product inspection.While a defect was observed, 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 ® 2
• 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: 21233459
• Report Number: 9610825-2024-01053
• Device Sequence Number: 8630490
• Product Code: FOZ
• UDI-Device Identifier: 04046955341979
• UDI-Public: (01)04046955341979(11)221104(17)271101(10)22M04G8271
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192676
• 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): 04/23/2025

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: 4232012-02
• Device Lot Number: 22M04G8271
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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