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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; SYRINGE, PISTON
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; SYRINGE, PISTON Back to Search Results
Model Number 328438
Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: lot #:medical device lot #: 0203534, expiration date: medical device expiration date: 31-jul-2025, device manufacture date: 21-jul-2020.Lot # medical device lot #: unknown, expiration date medical device expiration date: unknown, device manufacture date: unknown.
 
Event Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle that there seems to be something in some of the needles blocking the administration and plunger stops.The following information was provided by the initial reporter: there is something in some of the needles blocking the administration.Plunger stops.
 
Manufacturer Narrative
H6: investigation summary: customer returned (20) loose 3/10cc, 8mm syringes.Customer states that there seems to be something in some of the needles blocking the administration and plunger stops.All returned syringes were examined and tested and all were able to draw and expel properly without any observed defects.No foreign matter and no defects on the plunger rod were observed.A review of the device history record was completed for batch# 0203534.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
Event Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle that there seems to be something in some of the needles blocking the administration and plunger stops.The following information was provided by the initial reporter: there is something in some of the needles blocking the administration.Plunger stops.
 
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Brand Name
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Type of Device
SYRINGE, PISTON
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 Key14929245
MDR Text Key304332868
Report Number1920898-2022-00426
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908438032
UDI-Public00382908438032
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,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number328438
Device Catalogue Number328438
Device Lot Number2024620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2022
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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