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

Model Number 383322

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Inflammation (1932); Local Reaction (2035); Sepsis (2067); Skin Inflammation (2443)

Event Date 12/21/2020

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.(b)(4).

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system safety mechanism did not engage correctly over the needle during use.The following information was provided by the initial reporter: "safety mechanism did not engage correctly during deployment of the safe-t-intima as a subcutaneous device, the plastic covering did not engage over the end of the needle.No injury was incurred, and the device was able to be used for medication delivery".

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system safety mechanism did not engage correctly over the needle during use.The following information was provided by the initial reporter: "safety mechanism did not engage correctly during deployment of the safe-t-intima as a subcutaneous device, the plastic covering did not engage over the end of the needle.No injury was incurred, and the device was able to be used for medication delivery".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 3/8/2021 h.6.Investigation: a device history record review was completed for provided lot number 9224839.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a picture sample and a partial unit sample were returned for evaluation by our quality engineer team.The physical sample consisted of the cannula and safety device, which displayed the device correctly activated and the cannula was covered per the products function.The picture showed a partially activated safety shield.Based on the investigation results, it is possible that the unit was not correctly activated during use.According to the instructions for use, if the shield has not locked over the needle tip, grasp the textured end of the shield activator with the needle pointed down, and gently push downward until the needle is covered.See h.10.

• 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 ; MX
• MDR Report Key: 11175493
• MDR Text Key: 227039475
• Report Number: 9610847-2021-00015
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 383322
• Device Catalogue Number: 383322
• Device Lot Number: 9224839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1