MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THE

Catalog Number 4251129-02

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

As reported by the user facility: defective introcan - passive safety did not engage.Description of defect: safety closure mechanism did not work causing needle stick to rn.Midas was not immediately completed but will be completed momentarily.Rn and source patient tested as per employee exposure protocol.Staff stated that checked additional iv catheters from this same lot and they worked appropriately.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Through visual examination, it was observed that the safety clip was not engaged, and the cannula was bent.The safety clip had dislodged and the backwall was curved.The clip hole was inspected under 20x magnification, and no damages were observed.The cannula surface was inspected, and clip travel scratched lines were observed along the cannula.Cannula od was measured and the od measurements were consistent along the cannula and they are within specification.A simulation was performed on a reserved sample to replicate the defect.In the simulation, the cannula was withdrawn in a slanted angle (not following instruction for use), then the safety clip was dislodged, the clip arm deformed and the backwall was curved outward as a "v-shape" upon reaching the tip.The bending angle of the cannula was almost similar to the complaint sample.Based on the investigation, the defect is likely due to an application error.Therefore, we consider the complaint not confirmed.

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: 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: 17395949
• MDR Text Key: 320306113
• Report Number: 9610825-2023-00362
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046964014031
• UDI-Public: (01)04046964014031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 4251129-02
• Device Lot Number: 22L18G8951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1