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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 BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382523
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle had pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: the sheath of iv had been sheared by the needle before placement.The iv placement was attempted.Once the skin and vein were pierced with the needle, staff were unable to thread catheter and realized the needle had come out through part of the catheter and that was why they could not thread catheter.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-nov-2022.H6: investigation summary : our quality engineer inspected the sample submitted for evaluation.Bd received one 22gx1.00in insyte autoguard device from lot number 2146301.A gross visual inspection shows a catheter with media indicating that it has been used.Further microscopic inspection shows a catheter with a damage that has the v-shape form near the tip.The observed damage is identical to that created when the needle pierces the catheter wall near the tip giving a spear through, thus confirming the reported issue.The catheter and needle tip were inspected and found acceptable per specification.Although the reported issue was confirmed for a spear through, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, this may occur due to the alignment of the set together station, bent tubing, or air blow inconsistency.As the returned unit has been removed from the package and handled, it is also possible that the defect originated due to improper use either during tip adhesion break or during the venipuncture attempt in the clinician environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle had pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: the sheath of iv had been sheared by the needle before placement.The iv placement was attempted.Once the skin and vein were pierced with the needle, staff were unable to thread catheter and realized the needle had come out through part of the catheter and that was why they could not thread catheter.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
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 Key15819820
MDR Text Key306892567
Report Number1710034-2022-00713
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825234
UDI-Public(01)30382903825234
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382523
Device Catalogue Number382523
Device Lot Number2146301
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2022
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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