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

Catalog Number 383516

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/02/2023

Event Type  malfunction  

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

It was reported that bd nexiva metal foreign object was stuck on the catheter preventing needle separation.The following information was provided by the initial reporter translated from chinese to english: after the medical staff punctured the patient, they found that there was a metal foreign object stuck on the catheter, which prevented the needle core from being withdrawn.A reply letter is required, a complaint acceptance letter is required, no claim settlement is required, photos are required, and samples can be returned.

Manufacturer Narrative

Investigation results: received one unsealed 20ga x 1.00in.Nexiva unit.Visual inspection discovered that media was present indicating use.There appeared to be damage to the needle tip and catheter tip.Damage to the catheter tubing was also discovered.The cannula was able to fully disengage properly but with a slight ¿scratchy¿ feeling on the cannula and v clip.It wasn¿t enough to cause any resistance or issues with fully disengaging the cannula.No damage or dry adhesive was discovered inside the tip shield and the washer was loose within the tip shield.No metal foreign object was discovered in the catheter.The cannula was fully disengaged and removed to further inspect the catheter, but no foreign matter was discovered.Only media and damage to the catheter were discovered.The damage to the catheter tubing resembled a needle spear through, which may have occurred during use.The complaint states that they "found that there was a metal foreign object stuck on the catheter, which prevented the needle core from being withdrawn".The damage to the catheter may have been associated with the reported issue, whether is was needle puncture damage or other complication that may have occurred during use.During investigation no foreign metal object was discovered, and the needle was able to fully disengage without any significant resistance.The reported foreign material and functional complications could not be confirmed; however, the catheter damage and needle damage may have been contributing factors of the reported complications.If the needle punctured the tubing, the needle may have been mistaken for the metallic foreign material.A review of the device history record was performed, and a possible related quality issue was found during production that may relate to your reported issue.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defect of ¿needle disengagement difficult¿ and "foreign matter" could not be confirmed; however, potential contributing factors include the observed "catheter damage" and "needle blunt" damage.Probable root cause(s): undetermined.

Event Description

No additional information.

• Brand Name: BD NEXIVA
• 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: 18455163
• MDR Text Key: 332754856
• Report Number: 1710034-2023-01506
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• 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: 03/09/2024

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: Health Professional
• Device Catalogue Number: 383516
• Device Lot Number: 2312199
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1