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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
Catalog Number 381023
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2023
Event Type  malfunction  
Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
 
Event Description
It was reported that air entered the bd insyte¿ autoguard¿ bc shielded iv catheter line when negative pressure was applied.The following information was provided by the initial reporter, translated from japanese: "the report is about air drawn.When negative pressure was applied to an indwelling catheter, air was drawn.A close investigation of the complaint product is required.".
 
Event Description
It was reported that air entered the bd insyte¿ autoguard¿ bc shielded iv catheter line when negative pressure was applied.The following information was provided by the initial reporter, translated from japanese: "the report is about air drawn.When negative pressure was applied to an indwelling catheter, air was drawn.A close investigation of the complaint product is required.".
 
Manufacturer Narrative
Investigation summary: bd received an unsealed 22 gauge insyte autoguard blood control pro unit from an unknown lot number.Additionally, three photographs of the defective product were provided for investigation.A review of the device history record could not be performed as the reported lot was unknown and could not be identified from the returned unit or the provided photographs.Our quality engineer visually inspected the returned unit and identified that only the catheter was returned.There appeared to be damage to the bottom of the catheter adapter.Next, a leak test was performed and no leakage was observed.Finally, the device was flushed and aspirated using a syringe while submerged in water to detect for any possible leaks but no leaks were found.Therefore, based off the visual inspection the engineer was unable to verify any issues with air bubbles or leakage but could identify damage to the adapter.This damage could potentially cause air bubbles or air in line if used.Unfortunately, the engineer was unable to determine a definitive root cause for the observed damage.
 
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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
8448235433
MDR Report Key17076561
MDR Text Key316689774
Report Number1710034-2023-00631
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
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 06/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received06/28/2023
Supplement Dates FDA Received07/14/2023
Was Device Evaluated by Manufacturer? Yes
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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