MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75"; INTRAVASCULAR CATHETER

Model Number 383531

Device Problem Contamination (1120)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

It was reported while using bd nexiva dual port with q-syte, 24g x 0.75" foreign matter was found in the fluid pathway.The following information was provided by the initial reporter: this is a report about dirt inside the needle cover of nexiva.According to the customer's report, dirt was found inside the needle cover of nexiva after unpacking before use.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Lot number was not reported; however, a potential lot number was provided.The information for that number is as follows: medical device lot #:1155068.Medical device expiration date:31may2024.Device manufacture date:04apr2021.Medical device lot #:1091027.Medical device expiration date:31mar2024.Device manufacture date:01apr2021.Medical device lot #:1091940.Medical device expiration date:31mar2024.Device manufacture date:01apr2021.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 dual port with q-syte, 24g x 0.75" foreign matter was found in the fluid pathway.The following information was provided by the initial reporter: this is a report about dirt inside the needle cover of nexiva.According to the customer's report, dirt was found inside the needle cover of nexiva after unpacking before use.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of the provided batch numbers.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

• Brand Name: BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75"
• 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: 14242189
• MDR Text Key: 290446337
• Report Number: 1710034-2022-00222
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: 30382903835318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383531
• Device Catalogue Number: 383531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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