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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 YEL 24GA X .75IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD YEL 24GA X .75IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381812
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2024
Event Type  malfunction  
Event Description
It was reported that bd insyte autoguard yel 24ga x.75in needle wouldn't retract.The following information was provided by the initial reporter, translated from french to english: users have reported that when opening the catheter packaging, the plastic catheter falls out of the needle even before handling + inability to retract the needle.
 
Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The customer provided the event date number and confirmed that there were no serious injuries or interventions needed.
 
Event Description
It was reported that bd insyte autoguard yel 24ga x.75in needle wouldn't retract.The following information was provided by the initial reporter, translated from french to english: users have reported that when opening the catheter packaging, the plastic catheter falls out of the needle even before handling + inability to retract the needle.Additional information received 3/13/2024: can you specify the date of the event? 17 /02/2024.Have there been any serious injuries or adverse events? no.Were any medical or surgical interventions necessary? no.Were there any accidental sticks? if so, was it a device used or not? a priori no.
 
Event Description
No additional information.
 
Manufacturer Narrative
Investigation results: the complaint that the needle could not be retracted was confirmed from the photograph that was provided for investigation.The photo showed an insyte autoguard needle and shield without the iv catheter.The needle remained fully extended from the grip.Without the physical sample, the root cause of the damage could not be determined.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Although the root cause of the complaint could not be determined, a trend was identified for needle retraction failure complaints and a capa was opened to address this issue.This complaint type and corrective action will continue to be monitored for effectiveness.
 
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Brand Name
BD INSYTE AUTOGUARD YEL 24GA X .75IN
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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18889253
MDR Text Key337532566
Report Number1710034-2024-00176
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818129
UDI-Public(01)00382903818129
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 Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 04/12/2024
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 Number381812
Device Lot Number3124029
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received03/13/2024
04/12/2024
Supplement Dates FDA Received03/22/2024
04/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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