MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number 383511

Device Problem Contamination (1120)

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

Event Date 01/23/2023

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.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 24 ga 0.75 in foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about foreign matter on nexiva.According to the customers report, mold-like fm was found to be adhering to the product.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 15-feb-2023.H6: investigation summary: bd received a 24 gauge nexiva unit from lot 2223196 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed black specks of foreign matter (fm) embedded on the wing adapter.The device's packaging was also returned opened but the device and all of its components were present.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that due to the location and appearance of the fm it was burnt particulate resin that became embedded into the mold during the manufacturing process.Burnt embedded resin specks result from material build up in the barrel/screw.As the material flowed through the barrel/screw the buildup material can break free and end up embedded in the mold.Molds are purged between the lots to avoid the buildup of the burnt/loose material but one lot can sometimes take up to ten days to produce and this defect can happen.The observed defect was not in the fluid path and did not affect the fit, form, or function of the product.H3 other text : see h10.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 24 ga 0.75 in foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about foreign matter on nexiva.According to the customer's report, mold-like fm was found to be adhering to the product.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16369606
• MDR Text Key: 309568505
• Report Number: 1710034-2023-00102
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: Other
• Device Catalogue Number: 383511
• Device Lot Number: 2223196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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