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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVENOUS CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVENOUS CATHETER Back to Search Results
Model Number 381812
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2022
Event Type  malfunction  
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced catheter separation from hub.The following information was provided by the initial reporter, translated from spanish to english: catheter comes out from security (fixation) too often.
 
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 the bd insyte¿ autoguard¿ shielded iv catheter experienced catheter separation from hub.The following information was provided by the initial reporter, translated from spanish to english: catheter comes out from security (fixation) too often.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 2087238.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16163164
MDR Text Key308750294
Report Number1710034-2022-00918
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818129
UDI-Public(01)00382903818129
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381812
Device Catalogue Number381812
Device Lot Number2087238
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/23/2022
Initial Date FDA Received01/13/2023
Supplement Dates Manufacturer Received02/28/2023
Supplement Dates FDA Received03/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2022
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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