MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Material Fragmentation (1261)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.An additional lot number was provided in this complaint for material number 383516.Lot # 3244630 mnf date sept 01, 2023 exp date aug 31, 2026.

Event Description

It was reported that bd nexiva 20 ga x 1 in single port are having issues with the catheter tip integrity.The following information was provided by the initial reporter: "staff unable to properly place ivs, unable to pierce the skin due to the extra piece of plastic on the tip.".

Manufacturer Narrative

Investigation results: received 140 from lot 3256822 and 20 units from lot 3244630 of 20gx1.00in nexiva device for the investigation of this complaint.A gross visual inspection shows that the units are sealed in their packaging with no physical defect.Per the customer verbatim, they experienced difficulty piercing the skin due to extra piece of plastic material on the tip of the units.The units were investigated using quality testing procedures.All the units from both lots were within specification.A visual observation showed no damage or defects at the catheter tip.A functional test to measure the forces from needle tip penetration, catheter tip penetration, and catheter drag revealed that the measurements were within specification.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defect of catheter tip integrity was not confirmed.Probable root cause conclusion(s): not determined: a root cause cannot be determined in the absence of a confirmed defect.

Event Description

No additional information.

• Brand Name: BD NEXIVA 20 GA X 1 IN SINGLE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18726742
• MDR Text Key: 335766685
• Report Number: 1710034-2024-00113
• Device Sequence Number: 1
• Product Code: FOZ
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: Other
• Device Catalogue Number: 383516
• Device Lot Number: 3256822
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1