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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 381433
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
It was reported that at least one bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: a case of iv catheters are not retracting properly into the hub.
 
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
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received 154 sealed 20g x 1.00in.Insyte autoguard units from lot number 1187258.A gross visual inspection of the returned units did not find any damage to the components.76 of the units were randomly selected to be functionally tested for needle retraction time.45 of the tested units were found to be out of specification with the result of slow retraction time or no retraction at all within the test time period.The remaining units were then tested by inspecting and retracting them with the catheter adapter removed from the unit.Inspection found that there was excessive gel visible in the grip.No other anomalies were noted on the components or spring.When tested, the units retracted slowly, indicating that the slow retraction was not being caused by the catheter adapter.This left the needle assembly as the source of the defect, and as no other damage other than the excessive gel was found it is likely that excessive gel was causing the defect of slow retraction.The reported issue was confirmed.This type of defect may occur during manufacturing due to an incorrect amount of gel to be dispensed.Operators periodically measure the gel inside the grip by weighing the units before and after gel insertion and perform functional testing for needle retraction per the sampling plan 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.
 
Event Description
It was reported that at least one bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: a case of iv catheters are not retracting properly into the hub.
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12754611
MDR Text Key285224767
Report Number1710034-2021-00951
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903814336
UDI-Public00382903814336
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 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381433
Device Catalogue Number381433
Device Lot Number1187258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2021
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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