MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383322

Device Problems Collapse (1099); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Chemical Exposure (2570)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system stopped working after placing in the vein and flushing, and "sprayed radioactive tracer in faces".Attempts were made to reach out to the customer for additional information regarding medical intervention, but no additional information was received.The following information was provided by the initial reporter: "catheter just stops working for no reason.Whole system collapses.Put it in easy and flushes well and then just stops working.Has sprayed radioactive tracer in faces".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8332544.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system stopped working after placing in the vein and flushing, and "sprayed radioactive tracer in faces".Attempts were made to reach out to the customer for additional information regarding medical intervention, but no additional information was received.The following information was provided by the initial reporter: "catheter just stops working for no reason.Whole system collapses.Put it in easy and flushes well and then just stops working.Has sprayed radioactive tracer in faces.".

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8519159
• MDR Text Key: 142187416
• Report Number: 9610847-2019-00302
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: 30382903833222
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 383322
• Device Lot Number: 8332544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other