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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381211
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
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 3 bd insyte-n¿ autoguard¿ shielded iv catheters experienced the needle piercing through the catheter during catheter introduction.The following information was provided by the initial reporter: when the needle is inserted it pierces the catheter.
 
Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
 
Event Description
It was reported that 3 bd insyte-n¿ autoguard¿ shielded iv catheters experienced the needle piercing through the catheter during catheter introduction.The following information was provided by the initial reporter: when the needle is inserted it pierces the catheter.
 
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Brand Name
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED 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 Key15947871
MDR Text Key307881856
Report Number8041187-2022-00711
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier50382903812115
UDI-Public30382903812111
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381211
Device Catalogue Number381211
Device Lot Number1363105
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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