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

Model Number 4253566-02

Device Problems Fail-Safe Problem (2936); Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: safety on catheter did not engage which resulted in needlestick.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used sample was received for evaluation.Upon visual inspection it was observed that the safety clip was deformed.This product is subjected to a 100% inspection by an in-line vision system that is calibrated and subjected to regular verifications to ensure it is functioning properly.The defect observed in the returned sample would have been detected and rejected by the in-line vision system.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11798585
• MDR Text Key: 267720364
• Report Number: 9610825-2021-00157
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963318253
• UDI-Public: (01)04046963318253
• Combination Product (y/n): N
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4253566-02
• Device Catalogue Number: 4253566-02
• Device Lot Number: 20D01G8261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1