MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383591

Device Problems Break (1069); Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 02/03/2022

Event Type  Injury  

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 when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the catheter separating from the hub, breaking the needle from the device.Medical intervention at bedside occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the consumer bleeding at the site, catheter sheath missing and foreign body was removed from patient at bedside.At insertion of a bd nexiva diffusics 22 gauge 1 inch catheter into the left cephalic ac vein bleeding was noted at the puncture site.The iv hub was removed as bleeding at the insertion site is abnormal upon removal of the hub there was no catheter sheath attached to the hub.X-ray was performed and a 2.9 cm linear radiopaque foreign body of the lateral aspect of the antecubital fossa was seen and consistent with a retained iv cannula.Patient was transported to the emergency department and the foreign body was removed at the bedside.

Event Description

It was reported when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the catheter separating from the hub, breaking the needle from the device.Medical intervention at bedside occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the consumer bleeding at the site, catheter sheath missing and foreign body was removed from patient at bedside.At insertion of a bd nexiva diffusics 22 gauge 1 inch catheter into the left cephalic ac vein bleeding was noted at the puncture site.The iv hub was removed as bleeding at the insertion site is abnormal upon removal of the hub there was no catheter sheath attached to the hub.X-ray was performed and a 2.9 cm linear radiopaque foreign body of the lateral aspect of the antecubital fossa was seen and consistent with a retained iv cannula.Patient was transported to the emergency department and the foreign body was removed at the bedside.

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the mdr 9610847-2022-00122 is a duplicate of 9610847-2022-00073 this supplemental is to cancel mdr 9610847-2022-00122.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER 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: 13934878
• MDR Text Key: 288879516
• Report Number: 9610847-2022-00122
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: 00382903835911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383591
• Device Lot Number: 1209927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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
• Patient Outcome(s): Other