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

Catalog Number 383531

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Local Reaction (2035)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.(b)(6).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 a bd nexiva¿ closed iv catheter system had caused an allergic reaction.The following was reported by the customer, "a patient who was receiving iv clindamycin and flucloxacillin seems to be reacting to cannulae at present.Within 24 hrs of a cannula being insert a red inflamed area appears just at the insertion site.The patient was recannulated at least every 24 hrs and so had multiple sites on both arms as the nurses thought he had phlebitis at the sites.There are no other signs of reaction anywhere else, the sites are not painful just itchy.On saturday night they decided to switch the patient to oral antibiotics and removed all cannulae.Within 12 hrs all areas where the cannulae had been had returned to normal expect for one area on his left arm.".

Manufacturer Narrative

No samples or photos were provided for observation and/or testing of this incident.Dhr and sap (qn) reviews; were not conducted because a lot number was not provided for this incident.Without units or photos provided for observation and/or testing of this incident the alleged defect of irritation/inflammation could not be identified nor confirmed and a definite root cause could not be established.

Event Description

It was reported that a bd nexiva closed iv catheter system had caused an allergic reaction.The following was reported by the customer, "a patient who was receiving iv clindomycin and flucloxacillin seems to be reacting to cannulae at present.Within 24hrs of a cannula being insert a red inflamed area appears just at the insertion site.The patient was recannulated at least every 24hrs and so had multiple sites on both arms as the nurses thought he had pheblitis at the sites.There are no other signs of reaction anywhere else, the sites are not painful just itchy.On saturday night they decided to switch the patient to oral antibiotics and removed all cannulae.Within 12hrs all areas where the cannulae had been had returned to normal expect for one area on his left arm.".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: IV CATHETER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7936294
• MDR Text Key: 122788467
• Report Number: 1710034-2018-00671
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: 30382903835318
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 383531
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention