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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393222
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 there was a defect in the bd venflon¿ pro safety shielded iv catheter's white cap, which was loose and separated from the catheter during use.The following information was provided by the initial reporter, translated from french to english: "lot number 8225228p01 has a defect in the white cap at the end of the device.The cap falls, does not stay in place during use.".
 
Event Description
It was reported that there was a defect in the bd venflon¿ pro safety shielded iv catheter's white cap, which was loose and separated from the catheter during use.The following information was provided by the initial reporter, translated from french to english: "lot number 8225228p01 has a defect in the white cap at the end of the device.The cap falls, does not stay in place during use.".
 
Manufacturer Narrative
Investigation: bd was unable to verify the reported issue.Seven shelf cartons of representative samples were returned.The 350 samples were subjected to functional testing, dimensional measurement, and visual inspection.Functional test: 50 samples were subjected to flow control plug (fcp) disassembly force and end cap disassembly force functional test.Dimensional measurement: 20 samples were subjected to fcp dimension b measurement and end cap thread id measurement.Visual inspection: all 30 samples were subjected to visual inspection to check for defect and abnormality.The samples passed the inspection.No damage or abnormality was observed.The complaint is unverified as no defect is observed on the sample.As the representative samples passed the acceptance criteria, a review of the past 12 months qn for catalog 393222 was performed.There is no related qn on defect or condition of cap loose.
 
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Brand Name
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8455985
MDR Text Key140159916
Report Number8041187-2019-00256
Device Sequence Number0
Product Code FOZ
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 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number393222
Device Lot Number8225228
Date Manufacturer Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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