MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY; INTRAVASCULAR CATHETER

Catalog Number 391662

Device Problem Backflow (1064)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd venflon¿ pro safety ther was blood backflow during blood draw.The following was received by the initial reporter: upon insertion, there is no back flow which make the staff do little manipulation which causes bulging of the vein and so, causing multiple pricks for patients.The needle is long, the hub is heavy.In nicu, we are collecting laboratory samples during first iv cannula insertion to avoid many pricks.But with bd it is difficult to collect blood sample.The distance of needle from the hub is long, so the blood being accumulated in the hub is more before its drops to the specimen collection bottle.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 while using the bd venflon¿ pro safety ther was blood backflow during blood draw.The following was received by the initial reporter: upon insertion, there is no back flow which make the staff do little manipulation which causes bulging of the vein and so, causing multiple pricks for patients.The needle is long, the hub is heavy.In nicu, we are collecting laboratory samples during first iv cannula insertion to avoid many pricks.But with bd it is difficult to collect blood sample.The distance of needle from the hub is long, so the blood being accumulated in the hub is more before its drops to the specimen collection bottle.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 14-sep-2023.H.6.Investigation summary: our quality engineer inspected the 3 representative samples submitted for evaluation.The reported issue of aspirate draw/ difficult was not confirmed upon inspection of the sample.All the returned representative samples passed the flashback test; hence they were not occluded.Currently, flashback test is performed during routine outgoing inspection as a control to detect needle occlusion.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VENFLON¿ PRO SAFETY
• Type of Device: INTRAVASCULAR 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17702708
• MDR Text Key: 322884753
• Report Number: 8041187-2023-00471
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903916627
• UDI-Public: (01)00382903916627
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K201717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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: 391662
• Device Lot Number: 2299529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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