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

Catalog Number	391662
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8041187-2023-00471
• Device Sequence Number: 15111108
• Product Code: FOZ
• UDI-Device Identifier: 00382903916627
• UDI-Public: (01)00382903916627
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 391662
• Device Lot Number: 2299529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown