MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ PRO IV CANNULA; INTRAVENOUS CATHETER

Catalog Number 391350

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd neoflon¿ pro iv cannula experienced blood exposure.The following information was provided by the initial reporter: the customer needed to use a new product 4 times as they didn't go through the skin of the child.This is happening to often lately.Samples available.No sample or photos available.The incident occurred during use.Was there blood or biological fluid exposure? yes.Was there mucous membrane exposure? no.Was there medical/surgical intervention due to the incident? no.Were there other actions taken in the treatment of the patent/clinician as a result of the incident? no they used a different needle.They had to use a new product 4 times.

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 number 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.H3 other text : see h10.

Event Description

It was reported that the bd neoflon¿ pro iv cannula experienced blood exposure.The following information was provided by the initial reporter: the customer needed to use a new product 4 times as they didn't go through the skin of the child.This is happening to often lately.Samples available.No sample or photos available.The incident occurred during use.Was there blood or biological fluid exposure? yes.Was there mucous membrane exposure? no.Was there medical/surgical intervention due to the incident? no.Were there other actions taken in the tratment of the patent/clinician as a result of the incident? no they usend a different needle.They had to use a new product 4 times.

• Brand Name: BD NEOFLON¿ PRO IV CANNULA
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15987305
• MDR Text Key: 308378984
• Report Number: 8041187-2022-00735
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IC
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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 Catalogue Number: 391350
• Device Lot Number: 1324034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2021
• 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