MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problem Material Discolored (1170)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system - dual port had discolored blister packs.The following information was provided by the initial reporter, translated from spanish to english: the difference in the tonality of the plastic does not affect or jeopardize the use of the product.Bd representative informs that the parts in inventory that pronamac has with this issue is that the transparent plastic is a bit opaque on one of its edges.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.The discoloration was confirmed to be a non-issue, therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system - dual port had discolored blister packs.The following information was provided by the initial reporter, translated from spanish to english: the difference in the tonality of the plastic does not affect or jeopardize the use of the product.Bd representative informs that the parts in inventory that pronamac has with this issue is that the transparent plastic is a bit opaque on one of its edges.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17346916
• MDR Text Key: 319383580
• Report Number: 1710034-2023-00811
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: 00382903835324
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 08/10/2023

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: 383532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/15/2023
• 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