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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shield was separated from the barrel when the hcp removed the shield.
 
Manufacturer Narrative
Initial reporter phone# : (b)(6).Initial reporter zip code : (b)(6).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 the bd ultra fine¿needle hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shield was separated from the barrel when the hcp removed the shield.
 
Manufacturer Narrative
H6: investigation summary: no samples were returned therefore the investigation was performed based on the photos provided.Photos of a 0.3ml bd insulin syringe were provided.The customer reported that the needle with the shield was separated from the barrel when the hcp removed the shield.The photos were examined, and it was observed that the needle hub/shield assembly was detached from the barrel.No damage to the barrel tip was observed.Bd was able to confirm the customer¿s indicated failure based on the photos received.Capa pr1630423 has been opened to address this issue h3 other text : see h10.
 
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Brand Name
BD INSULIN SYRINGES WITH THE 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 Key13122371
MDR Text Key284386663
Report Number1920898-2021-01356
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2022
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 Health Professional
Device Catalogue Number326631
Device Lot Number1116769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/20/2022
Supplement Dates FDA Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2021
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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