MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383511

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that nexiva 24 ga x 3/4 in single port was damaged.The following information was provided by the initial reporter: before use, the hcp noticed that the push tab was damaged.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/22/2020.H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one un-retracted unit and four photos.Upon initial inspection of the photos and the received sample, it was found that the tip shield was cracked, confirming the reported defect.The grip was inspected for any signs of damage.A minor scratch was observed on the grip, however no other major damage or indentations were found.This indicated that the damage most likely occurred during the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that nexiva 24 ga x 3/4 in single port was damaged.The following information was provided by the initial reporter: before use, the hcp noticed that the push tab was damaged.

• Brand Name: NEXIVA 24 GA X 3/4 IN SINGLE PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11152572
• MDR Text Key: 227071210
• Report Number: 1710034-2021-00018
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: 00382903835119
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383511
• Device Lot Number: 0163980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1