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

Catalog Number	4251622-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As per medwatch report # (b)(4): describe the event or problem: healthcare provider called to do an ultrasound guided peripheral intravenous line (piv) on patient with arm restriction due to presence of arteriovenous fistulas (avf) on left arm.Introcan safety® deep access iv catheters, 22ga, 2.5in.Ultrasonography (usg) piv placed to right upper arm.Insertion went smoothly-flash to blood chamber noted.As soon as i tried to separate catheter from needle, the needle just came off from the rest of the catheter.I was able to retrieve rest of needle from insertion site then safety device was engaged.Needle is all intact, did not appear bent or fractured.What was the original intended procedure? : placement of ultrasound guided peripheral intravenous line (piv) what problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do; no injury reported.
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 sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to 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.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER, INTRAVASCULAR, THE,
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabs 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: 18443414
• Report Number: 9610825-2023-00650
• Device Sequence Number: 6929982
• Product Code: FOZ
• UDI-Device Identifier: 04046964826023
• UDI-Public: (01)04046964826023
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 4251622-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 89 YR
• Patient Sex: Female
• Patient Race: White