MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVENOUS CATHETER

Catalog Number 383522

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 with the use of the nexiva 22 ga x 1.00in sp that there are grooves underneath the stabilization platform and septum that are causing lacerations on frail skin.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation: according the customer information per ¿other¿ defect condition, the sample received was analyzed visually.It did not show any flash or plastic excess underneath stabilization platform and septum of device which could cause a lacerations on skin.During the visual inspection this sample showed a good visual condition without hurt on the area of device mentioned before.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the visual inspection of the returned sample.A review of the device history and manufacturing records revealed no related issues related to damaged components.We could not confirm a specific root cause for this issue since the actual sample received didn¿t show any issue related to the incident reported.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7022582
• MDR Text Key: 92371010
• Report Number: 1710034-2017-00318
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835523
• UDI-Public: 30382903835523
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383522
• Device Lot Number: 7177667
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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