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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 329605
Device Problems Leak/Splash (1354); Misconnection (1399); Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Event Description
It was reported while using bd autoshield¿ duo the user was unable to deliver insulin.There was no report of patient impact.The following information was provided by the initial reporter: description of the incident: the team noticed a large drop of insulin on the patient's skin after the injection and a disturbed blood sugar level afterwards.
 
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 while using bd autoshield¿ duo the user was unable to deliver insulin.There was no report of patient impact.The following information was provided by the initial reporter: description of the incident: the team noticed a large drop of insulin on the patient's skin after the injection and a disturbed blood sugar level afterwards.
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
 
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Brand Name
BD AUTOSHIELD¿ DUO
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16010810
MDR Text Key308116939
Report Number9616656-2022-01379
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeFR
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 12/26/2022
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 Number329605
Device Lot Number2091886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received01/06/2023
Supplement Dates FDA Received01/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2022
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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