MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number 383536

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva, unable to connect flush to adaptor.The following information was provided by the initial reporter, translated from french to english: when inserting a venous access, it is impossible to connect the bidirectional valve to the pre-filled syringe.Impossible to inject the liquid.After checking the two-way valves, i realize that there are no "holes" in the plugs.So it's impossible to connect anything.Clinical consequences : catheter change.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

When inserting a venous access, it is impossible to connect the bidirectional valve to the pre-filled syringe.Impossible to inject the liquid.After checking the two-way valves, i realize that there are no "holes" in the plugs.So it's impossible to connect anything.Clinical consequences : catheter change.I'm holding the faulty device at your disposal for expert appraisal, and i look forward to hearing from you.

Manufacturer Narrative

Current control there is in-process and outgoing visual inspection for missing and damage components.From the returned sample, the qsyte and vent plug was able to be removed and there are the ¿hole¿ where the luer lock and luer slip syringe is able to be attached to it.Thus the defect could not be confirmed.As there is no abnormality during the production run and outgoing inspection, root cause could not be determined.

• Brand Name: BD NEXIVA
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18352414
• MDR Text Key: 330827064
• Report Number: 1710034-2023-01454
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383536
• Device Lot Number: 3114092
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1