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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 0.9MM X 25MM; INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 0.9MM X 25MM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393202
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Code Available (3191)
Event Date 02/01/2019
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 a malfunction occurred with a venflon pro 0.9mm x 25mm.The following information was provided by the initial reporter, "the incident occurred in the radiology department in the hospital.The product was placed successful in the patients vein, on the hand.When the nurse should remove the needle from the vialon-catheter, the needle stuck/couldn't get out.She had to remove the whole catheter from the patient.The patient had to get one more needlestick.".
 
Manufacturer Narrative
H.6.Investigation summary: since no samples or photos displaying the condition reported are available for examination, we were unable to fully verify this incident.A review of the device history record revealed no irregularities during the manufacture of the reported lot.While we were unable to confirmed this report, the nonconformance may have occurred during manufacturing due to the gradual choking of the silicone filter supply line.A preventive maintenance requirement was implemented to check the silicone filter regularly.Additionally, the system alarm for the choking of the filter will be optimized to prevent future occurrences of this type.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants an additional formal corrective action, resources will be assigned at that time.
 
Event Description
It was reported that a malfunction occurred with a venflon pro 0.9mm x 25mm.The following information was provided by the initial reporter, "the incident occurred in the radiology department in the hospital.The product was placed successful in the patients vein, on the hand.When the nurse should remove the needle from the vialon-catheter, the needle stuck/couldn't get out.She had to remove the whole catheter from the patient.The patient had to get one more needlestick".
 
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Brand Name
VENFLON PRO 0.9MM X 25MM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8701590
MDR Text Key149709196
Report Number8041187-2019-00459
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903932023
UDI-Public382903932023
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number393202
Device Lot Number8108168
Initial Date Manufacturer Received 05/27/2019
Initial Date FDA Received06/14/2019
Supplement Dates Manufacturer Received05/27/2019
Supplement Dates FDA Received06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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