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

Catalog Number	383531
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem 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 or Problem Description
This is a report about foreign matter on nexiva.According to the customer's report, ink like scattered stains on the product.
Additional 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
• Common Device Name: 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
• Report Number: 2243072-2024-00219
• Device Sequence Number: 15261695
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: (01)30382903835318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 383531
• Device Lot Number: 3208656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown