MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383557

Device Problem Defective Device (2588)

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

Event Date 05/13/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector was defective.The following information was provided by the initial reporter: nexiva catheter was defective right out of the package.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed an opened 20g x 1.25in.Nexiva unit.A gross visual inspection of the unit found that the extension tubing, needle, needle cover, and catheter tubing had been cut.Additionally, voids in the packaging seal were present and parts of the extension tubing where flattened.Based on these observations, it is likely that the unit was caught in the seal of the packaging.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error.This type of defect may occur during manufacturing due to misalignment when the pick and place robot is placing the unit in the package.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector was defective.The following information was provided by the initial reporter: nexiva catheter was defective right out of the package.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17095520
• MDR Text Key: 317830331
• Report Number: 1710034-2023-00645
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903835577
• UDI-Public: 00382903835577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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: 383557
• Device Lot Number: 3059752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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