MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. INTROCAN SAFETY; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 4252527-02

Device Problems Difficult to Flush (1251); Kinked (1339); Torn Material (3024)

Patient Problem Pain (1994)

Event Date 01/12/2018

Event Type  malfunction  

Event Description

The patient was transferred from a outside user facility.The rn had trouble flushing the iv line.Attempt to flush line in the right upper arm caused a lot of pain for the patient.The line could not be flushed.There was a hard plastic-like bulge felt where catheter should be.The line was pulled and found to be very kinked.The tip seemed to be torn off.The provider was notified.A concern for the retained tip was noted and disclosure to the patient was done.Multiple diagnostic exams were performed to locate the tip of iv line.There was no verification by an exam that there was a retained foreign object.The original iv was sequestered and given to risk management.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7348799
• MDR Text Key: 102762830
• Report Number: 7348799
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018,03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 4252527-02
• Device Lot Number: 16F13G8241
• Other Device ID Number: 20G
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR