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 Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/29/2018

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 a lump that formed on the skin after removal of catheter.No discomfort and couldn't be defined as anything other than a nodule.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 7143717.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.Bd was not able to confirm the customer¿s indicated failure modes according evaluated photos.Customer reported reaction and leakage issues; nevertheless, no sample was received for evaluation.After analyze both photos by the engineering team, we cannot confirm or associate the reported defects to manufactured process due to 2 photos only showed lump on the skin.Unfortunately, we could not be identified the root cause due to the unit described in the product incident report was not returned for evaluation and testing, which is essential to perform a better investigation.We could not found the root cause of these issues.Certificate of sterility met with acceptance criteria.

Event Description

It was reported with the use of the bd saf-t-intima¿ iv catheter safety system there was an issue with a lump that formed on the skin after removal of catheter.No discomfort and couldn't be defined as anything other than a nodule.

• 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: 8330590
• MDR Text Key: 135859263
• Report Number: 9610847-2019-00148
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 383313
• Device Lot Number: 7143717
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other