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 Problem Defective Device (2588)

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

Event Date 08/09/2018

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 with the use of the bd saf-t-intima¿ iv catheter safety system there was an issue with safety mechanism not covering needle.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd saf-t-intima iv catheter safety system there was an issue with safety mechanism not covering needle.There was no report of injury or medical intervention.

Manufacturer Narrative

A device history review was conducted for lot number 7300685, our records show it was manufactured on november 11, 2017; it was determined that this is the only instance of a needle retraction failure occurring in this lot.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 of packaged goods.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.Therefore, we cannot confirm or associate this complaint to the manufacturing process.Bd will continue to monitor this issue.No corrective action was performed 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
• MDR Report Key: 7821358
• MDR Text Key: 118529867
• Report Number: 9610847-2018-00298
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 10/31/2021
• Device Catalogue Number: 383329
• Device Lot Number: 7300685
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other