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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381823
Device Problems Decoupling (1145); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  malfunction  
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 when using the bd¿ insyte autoguard shielded iv catheter, the device experienced foreign matter in the fluid path of the cannula, along with the device not being able to connect to the mating component.The following information was provided by the initial reporter.The customer stated: reports of extra piece of plastic at opening of cannula, causing difficulty with attaching tubing for iv contrast, resulting in recannulation of patient.
 
Event Description
It was reported when using the bd¿ insyte autoguard shielded iv catheter, the device experienced foreign matter in the fluid path of the cannula, along with the device not being able to connect to the mating component.The following information was provided by the initial reporter.The customer stated: reports of extra piece of plastic at opening of cannula, causing difficulty with attaching tubing for iv contrast, resulting in recannulation of patient.
 
Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-12-07.Investigation summary our quality engineer inspected the samples and photograph submitted for evaluation.Bd received 98 units and one photo.The photo showed a view of the end of a 22ga catheter adapter that had a smashed outer thread, confirming the reported defect.It was also noticed that there were traces of media and clear fluid present inside and outside the adapter.Upon inspection of the received units, it was observed that eight units had damaged to the outer threads and ten units had scuff markings on the adapter which is considered to be a cosmetic defect.The remaining units did not have any defects.It was also noted that the damage in the photo did not match the damage observed in the returned units.Damage to the outer threads of the adapter may prevent a connection to be achieved and result in leakage; therefore, function testing was performed on the damaged units.A secure connection was achieved for all eight units.The units were then tested for leakage.No leakage was observed from any of the damaged adapters.Although a secure connection was achieved and no leakage occurred, the reported defect was confirmed and determined to most likely be related to the manufacturing process.Damage to the luer may occur due to misalignment between the adapter and manufacturing equipment, resulting in excess force to the wall of the adapter.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
BD¿ INSYTE AUTOGUARD 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 Key12980469
MDR Text Key284828023
Report Number1710034-2021-01044
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2024
Device Model Number381823
Device Catalogue Number381823
Device Lot Number1040911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2021
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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