MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 24GA 0.75IN Y; INTRAVASCULAR CATHETER

Catalog Number 383531

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva 24ga 0.75in y had foreign matter the following information was provided by the initial reporter: this is a report about foreign matter on nexiva.According to the customer's report, ink like scattered stains on the product.

Event Description

This is a report about foreign matter on nexiva.According to the customer's report, ink like scattered stains on the product.

Manufacturer Narrative

Review of the dhr showed that the housekeeping is performed per shift with no abnormality observed.Current control there is a outgoing inspection and 2 hourly in-process inspection in place to check for foreign matter at z8.Due to no plug flow control sample returned to determine the foreign matter type, root cause could not be determined.The complaint will be re-opened and re-investigated if the vent plug flow control sample is returned.

• Brand Name: BD NEXIVA 24GA 0.75IN Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18794637
• MDR Text Key: 336396950
• Report Number: 2243072-2024-00219
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: (01)30382903835318
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 383531
• Device Lot Number: 3208656
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1