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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¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382544
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
It was reported that prior to using three of the bd insyte¿ autoguard¿ bc shielded iv catheters, foreign matter was found in catheter.The following information was provided by the initial reporter: we have some 18 ga iv catheters that appear to have orange specks inside them.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 14-apr-2022 h6: investigation summary our quality engineer inspected samples submitted for evaluation.Bd received two opened insyte autoguard units with an opened package and top web, and one unopened unit from lot number 1322255.Upon inspection of the three units only one of the units was observed to have foreign matter present.The foreign matter was located on the grip component of the device only.There was no foreign matter observed elsewhere.The foreign matter observed has a more red-brown appearance in the microscope but more of a reddish appearance under naked eye.A microscopic inspection was performed to determine identifiers which concluded that the foreign matter is red in color and can be wiped or scrapped away.The foreign matter was identified to not be a solid but be partially viscous as identified by scrapping it away.Additionally, the foreign appears to match its surface similar to that of the grip.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment as the device was returned opened.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
 
Event Description
It was reported that prior to using three of the bd insyte¿ autoguard¿ bc shielded iv catheters, foreign matter was found in catheter.The following information was provided by the initial reporter: we have some 18 ga iv catheters that appear to have orange specks inside them.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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 Key14253031
MDR Text Key290446141
Report Number1710034-2022-00225
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825449
UDI-Public30382903825449
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201075
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 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382544
Device Catalogue Number382544
Device Lot Number1322255
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2021
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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