MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETER

Catalog Number 383536

Device Problem Separation Failure (2547)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.

Event Description

It was reported that bd nexiva needle did not disengage.The following information was provided by the initial reporter: needle is not dislodging from device, causing it to get stuck and result in another stick.Additional info from customer: -what is the total quantity of products found defective? 10-20.-is there any adverse event or serious injury occurred? iv restart.-are you able to provide sample to bd for investigation? if no, can a photo be provided? if yes, please provide mailing address.Yes, please send shipping info.

Manufacturer Narrative

Investigation findings demonstrate the as analyzed code of failure to decouple which is not mdr reportable.Investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received 2 used 20gx1.25in needle assembly of a nexiva unit from lot number 3087440.A gross visual inspection shows that one unit has been decoupled from the catheter assembly and the second unit not.The returned tip of unit #1 shield was further inspected and a damage with a shape of a tear drop was observed inside the component.Unit 2 has blood indicating use.Upon attempting to decouple, a slight resistance was felt and upon coming off, the defect similar to unit #1 was observed.Your reported issue was confirmed as a failure to decouple.Further investigation was performed, and inspection of the tip shield revealed that plastic from the tip shield was catching the v-clip preventing release of the winged adapter.Based on the location of the damage, this most likely originated during the manufacturing process while inserting the cannula into the grip and tip shield.Operators perform in process sampling and testing for retraction throughout the manufacturing process.Preventative maintenance (pm's) are also performed periodically to ensure proper function of the equipment.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

No additional information to report.

• Brand Name: BD NEXIVA
• Type of Device: PERIPHERAL IV 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: 18059923
• MDR Text Key: 327289744
• Report Number: 1710034-2023-01242
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: (01)30382903835363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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: Health Professional
• Device Catalogue Number: 383536
• Device Lot Number: 3087440
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1