MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO; PERIPHERAL IV CATHETERS

Catalog Number 383552

Device Problems Mechanical Problem (1384); Difficult or Delayed Activation (2577)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva 22 ga x 1.00in sp with maxzero safety shielding did not engage.The following information was provided by the initial reporter: verbatim: during in servicing of product, pulled needle to safety it and safety did not engage.(b)(6) 2023.Is it ¿pulled needle to safety it and safety did not engage¿ is needle shielding failure? or safety mechanism not disengage from catheter or stuck at the hub? or difficult to remove the needle? : safety shielding failure.How many occurrences of defective set(s) affected? : 2 individual iv catheters.Was there any patient¿s involvement? : no, this was during inservicing.What was the patient outcome? : n/a.Was there any delay of, or change in, the course of treatment due to this event?: n/a.What procedure was being performed? : inservicing new product.What medication was used in the procedure? : n/a.Since sample is not available, are you able to provide the photo/video of the issue/defects? : n/a.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.The dhr for lot 3234051 has been reviewed.The dhr for lot 3234051 was built and packaged on nfa 3 from 03sep2023 through 06sep2023 for a quantity of (b)(4) no related quality issues or process deviations were found.

• Brand Name: BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18026959
• MDR Text Key: 326807056
• Report Number: 1710034-2023-01236
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835523
• UDI-Public: (01)30382903835523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: 383552
• Device Lot Number: 3234051
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/29/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1