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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 22GA 1.00; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
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 that 1 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1.00 that there was a tear in the catheter and leakage.The following information was provided by the initial reporter: for this product, the presence of a tear on the pink or blue part of the catheter was noticed, which causes a flow of the injected product or even a flow of blood.During the injection of an intravenous medication, a tear was found, so the patient did not get the entirety of the medication.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-07.H6: investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received fifty unopened units and two photos.Upon inspection of the customer photos, it was identified that fluid was present on the outside of the blue adapter.However, due to the quality of the photo no damage was visible and the defect could not be confirmed.The samples were then inspected and no damage was observed.Finally, the units were tested for leakage and no leakage was observed.Since the returned units met and performed per the required manufacturing specifications, bd was unable to confirm the reported defect.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 1 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1.00 that there was a tear in the catheter and leakage.The following information was provided by the initial reporter: for this product, the presence of a tear on the pink or blue part of the catheter was noticed, which causes a flow of the injected product or even a flow of blood.During the injection of an intravenous medication, a tear was found, so the patient did not get the entirety of the medication.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12854281
MDR Text Key285807103
Report Number1710034-2021-01003
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2024
Device Catalogue Number381023
Device Lot Number1111856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
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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