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 383313

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified?: the initial reporter also notified the fda october 2017 via medwatch # (b)(4).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 safety of a bd saf-t-intima iv catheter safety system did not engage after use.No injury or medical intervention.

Manufacturer Narrative

Investigation results: our quality engineer visually inspected the returned unit and confirmed that the needle had been completely activated and shielded.A review of the device history records revealed no irregularities during the manufacture of reported lot number 6243927.We cannot confirm or associate the reported defect to be associated with the manufacturing process with the provided information.We received only a complete activated safety device.This reported defect could be related with an incorrect use of the product by user and a possible cause is that after of finishing the puncture, user performed the activation since adapter sti prn was removing all the safety mechanisms and leaving exposed cannula.Conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined, however a possible cause could be the use incorrect of the device by user.No capa was opened since this issue could not be confirmed as manufacturing related.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7131832
• MDR Text Key: 95806503
• Report Number: 9610847-2017-00202
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383313
• Device Lot Number: 6243927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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
• Patient Outcome(s): Other