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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328440
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had hub separation issues.The following information was provided by the initial reporter : the returned syringe sample has experienced a needle hub separation.
 
Manufacturer Narrative
H6: investigation summary customer returned a single 0.3ml syringe with no pouch for identification.The syringe had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is a small section of material at the connector that has broken off.This is believed to be the result of user attempts to separate the shield from the syringe.A review of the device history record was completed for batch #1322258.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was able to confirm the customer¿s indicated failure of needle hub separation.Capa pr1630423 has been opened to address this issue.
 
Event Description
It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had hub separation issues.The following information was provided by the initial reporter : the returned syringe sample has experienced a needle hub separation.
 
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Brand Name
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14738721
MDR Text Key296059442
Report Number1920898-2022-00390
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/15/2022
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 Number328440
Device Lot Number1322258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/23/2022
Initial Date FDA Received06/17/2022
Supplement Dates Manufacturer Received08/15/2022
Supplement Dates FDA Received09/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2021
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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