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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 382523
Device Problem Defective Component (2292)
Patient Problem Pain (1994)
Event Date 01/31/2023
Event Type  malfunction  
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter tip was uneven and burred.The following information was provided by the initial reporter: "on close inspection the tips of the catheters are uneven, have burrs on the tips, are squared on one side vs tapered.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-feb-2023 h6: investigation summary bd received four 22 gauge insyte autoguard blood control units from lot 2290801 for evaluation.One unit was received in its sealed packaging while the other three were received opened.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical damage or deformities to the units.Next, each unit was tested for flashback and each unit was found to be within product specifications.The sealed unit was tested for catheter penetration force, needle penetration force, and catheter drag but no issues were found during inspection.However, the remaining three units received in opened packages could not be tested for the same procedures but were microscopically inspected for any damage to the catheter tubing and catheter tips.No damage was found and each unit was found to be acceptable and within product specifications.Finally, the engineer reviewed the provided photographs of the reported issue.Eight photos were provided for review and the engineer identified similar findings as the sample investigation with the exception of what appeared to be a burr on the catheter tip of the device.This was not present on the returned units and could not be investigated further.Therefore, based off the provided photos the engineer was able to verify that there was an issue with the catheter tips but could not verify any other issues.Unfortunately, since the defect was visible with the returned units and not other issues could be identified a definitive root cause could not be determined.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter tip was uneven and burred.The following information was provided by the initial reporter: "on close inspection the tips of the catheters are uneven, have burrs on the tips, are squared on one side vs tapered.".
 
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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 Key16438869
MDR Text Key310250687
Report Number1710034-2023-00142
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825233
UDI-Public00382903825233
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 04/05/2023
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 Number382523
Device Lot Number2290801
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2023
Initial Date FDA Received02/24/2023
Supplement Dates Manufacturer Received04/05/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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