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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381333
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 the bd insyte-w¿ iv catheter experienced a defective catheter.The following information was provided by the initial reporter: have had several catheters blow in a row making us concerned that this box may be defective.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 17-oct-2022.H6: investigation summary: our quality engineer inspected the 27 samples submitted for evaluation.The reported issue was not confirmed upon inspection of the samples.Analysis of the sample showed that there were no abnormalities on all the samples returned.A review of the used sample would be necessary to fully investigate this incident.Bd could not determine a root cause since the defect was not confirmed.
 
Event Description
It was reported that the bd insyte-w¿ iv catheter experienced a defective catheter.The following information was provided by the initial reporter: have had several catheters blow in a row making us concerned that this box may be defective.
 
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Brand Name
BD INSYTE-W¿ IV CATHETER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15678832
MDR Text Key306897093
Report Number8041187-2022-00622
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903813330
UDI-Public30382903813330
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381333
Device Catalogue Number381333
Device Lot Number2025564
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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