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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328431
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 insulin syringes with bd ultra-fine¿ needle there was a hole in the barrel and insulin leaked.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer/pet owner reported finding about 6 syringes from this box with holes in barrel.Found when drawing and also injecting.Can see the insulin coming out side of barrel syringe.
 
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 review of the device history record was completed for batch# 2094869.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that did not pertain to the complaint.H3 other text : see h10.
 
Event Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle there was a hole in the barrel and insulin leaked.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer/pet owner reported finding about 6 syringes from this box with holes in barrel.Found when drawing and also injecting.Can see the insulin coming out side of barrel syringe.
 
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Brand Name
BD INSULIN SYRINGES 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 Key15533093
MDR Text Key302003615
Report Number1920898-2022-00675
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328431
Device Lot Number2094869
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2022
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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