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 Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

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 that the stylet of the bd saf-t-intima¿ iv catheter safety system had a fold in it when removed from the packaging.The following information was provided by the initial reporter, translated from portuguese: "i remove an intima catheter 24 from the package, it has a significant fold in the guide wire.".

Event Description

It was reported that the stylet of the bd saf-t-intima¿ iv catheter safety system had a fold in it when removed from the packaging.The following information was provided by the initial reporter, translated from portuguese: "i remove an intima catheter 24 from the package, it has a significant fold in the guide wire".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of stylet damaged/defective was confirmed upon inspection of the photo.The photo showed a unit outside of its packaging with a bend in the joint of the stylet of the needle.This damage can potentially occur during the handling of the unit if not handled carefully since the wire can be bent easily.However, bd cannot confirm the cause of the failure since no sample was returned for evaluation.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16261500
• MDR Text Key: 309014437
• Report Number: 9610847-2023-00009
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: 00382903833139
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383313
• Device Lot Number: 1117631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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