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 383329

Device Problems Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd saf-t-intima¿ iv catheter safety system the needle safety mechanism doesn't work there was no report of injury or medical intervention.

Manufacturer Narrative

Investigion summary: based on sample evaluation and considering that device was received activated completely, we cannot confirm or associate the defects to manufacturing process.This reported defect could be related with an incorrect activation by user.A possible cause is that after of finishing the puncture, user performed the activation since adapter sti prn, removing all the safety mechanism and leaving exposed cannula.Dhr for lot number 6146726 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383329 with lot number 6146726 was manufactured on may 31, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During this lot number (b)(4) samples were activated by qa tech to perform 3 test of pull force.Stylet/cannula removal force through inserter wings, stylet/cannula removal force through the prn component, outer safety sheath disconnection force from prn component.No values out of specification or problems during activation were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.Investigation conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined; however, a possible cause can be during device activation by user.

• 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: 7310434
• MDR Text Key: 101572353
• Report Number: 9610847-2018-00037
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383329
• Device Lot Number: 6146726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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