MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DIFFUSICS 24G X 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383590

Device Problem Fail-Safe Problem (2936)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

It was reported while using bd nexiva diffusics 24g x 0.75 in the safety mechanism broke.There was no report of patient impact.The following information was provided by the initial reporter: it was reported, rn was placing a diffusics 24g on a patient when she threaded the catheter and pulled the needle back, the safety feature did not engage and popped right off the top with the whole needle exposed.No employee stick, no harm to patient.

Manufacturer Narrative

E.4.: the initial reporter also notified the fda on 08jun2023.Medwatch report #mw5118345 h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported while using bd nexiva diffusics 24g x 0.75 in the safety mechanism broke.There was no report of patient impact.The following information was provided by the initial reporter: it was reported, rn was placing a diffusics 24g on a patient when she threaded the catheter and pulled the needle back, the safety feature did not engage and popped right off the top with the whole needle exposed.No employee stick, no harm to patient.

• Brand Name: BD NEXIVA DIFFUSICS 24G X 0.75 IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17313541
• MDR Text Key: 319497537
• Report Number: 1710034-2023-00791
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835905
• UDI-Public: (01)30382903835905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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 Model Number: 383590
• Device Catalogue Number: 383590
• Device Lot Number: 3010847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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