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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L; CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L; CATHETER Back to Search Results
Catalog Number 393230
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that venflon pro safety 14ga 2.0mm od 45mm l leaked.The following information was provided by the initial reporter: i have just been informed we have a massive problem with bd pro-safety (14 and 16 g) in our theatres.As you can see from the photographs both blood and fluids are leaking from the port.This is happening cross site (sth and guys), with multiple lot numbers involved and they are present in 15 omnicell cabinets.It will be difficult to sequester the offending items but i have copied both tarvinder and greg for their assistance on how best to manage this situation,.The mrha has been notified.I cannot stress the urgency of this situation.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/16/2020.H.6.Investigation: six photos and two used samples were received by our quality team for evaluation.The first and second photo shows top webs from batch 0144811 and 0080448.The third photo shows a transparent liquid leaking from the injection port.The fourth and fifth photos show blood leaking from the injection port.The six photo shows two cannula hubs with different valve positions, one of the valves had moved towards the cannula hub.Upon visual inspection of the used samples, the valve was observed to have moved towards the cannula hub luer side.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of the leakage is due to the injection valve moving within the cannula hub.Capa# 1379444 has been initiated to address this issue.
 
Event Description
It was reported that venflon pro safety 14ga 2.0mm od 45mm l leaked.The following information was provided by the initial reporter: i have just been informed we have a massive problem with bd pro-safety (14 and 16 g) in our theatres.As you can see from the photographs both blood and fluids are leaking from the port.This is happening cross site (sth and guys), with multiple lot numbers involved and they are present in 15 omnicell cabinets.It will be difficult to sequester the offending items but i have copied both tarvinder and greg for their assistance on how best to manage this situation,.The mrha has been notified.I cannot stress the urgency of this situation.
 
Manufacturer Narrative
The following fields were updated due to additional information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0080448, d.4.Medical device expiration date: 3/31/2023, h.4.Device manufacture date: 3/20/2020.D.4.Medical device lot #: 0144811, d.4.Medical device expiration date: 5/31/2023, h.4.Device manufacture date: 5/23/2020.
 
Event Description
It was reported that venflon pro safety 14ga 2.0mm od 45mm l leaked.The following information was provided by the initial reporter: i have just been informed we have a massive problem with bd pro-safety (14 and 16 g) in our theatres.As you can see from the photographs both blood and fluids are leaking from the port.This is happening cross site (sth and guys), with multiple lot numbers involved and they are present in 15 omnicell cabinets.It will be difficult to sequester the offending items but i have copied both (b)(6) for their assistance on how best to manage this situation,.The mrha has been notified.I cannot stress the urgency of this situation.
 
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Brand Name
VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L
Type of Device
CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key11009485
MDR Text Key222021620
Report Number8041187-2020-00832
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number393230
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Date Manufacturer Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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