MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 18 GA X 1-1/4 IN SINGLE PORT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 383519

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Device problem code: a0203 - defective device.Patient problem code: f24 - insufficient information.

Event Description

Mat#: unknown.Batch#: unknown.It was reported by customer that after starting the iv, it was noticed there was a hole in the connected extension set.Blood leaked out of the hole.Due to the extension set being a part of the iv catheter the iv had to be removed and a new one started.

Event Description

Mat#: 383519, batch#: unknown.It was reported by customer that after starting the iv, it was noticed there was a hole in the connected extension set.Blood leaked out of the hole.Due to the extension set being a part of the iv catheter the iv had to be removed and a new one started.Verbatim: rcc received a complaint via email.Email(s).After starting the iv, it was noticed there was a hole in the connected extension set.Blood leaked out of the hole.Due to the extension set being a part of the iv catheter the iv had to be removed and a new one started.There is no other way to troubleshoot this when it happens.

Manufacturer Narrative

(b)(6) - follow up mdr for corrections.Initial mdr submitted with incorrect device information.The following corrections were made: site legal name updated to correct site.D tab: medical devie brand name updated.Common device name updated.Medical device type updated.510k updated.

• Brand Name: NEXIVA 18 GA X 1-1/4 IN SINGLE PORT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18110544
• MDR Text Key: 328049332
• Report Number: 9616066-2023-02175
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835196
• UDI-Public: (01)30382903835196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383519
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1