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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 Problem Defective Component (2292)
Patient Problem Pain (1994)
Event Date 10/24/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringes with bd ultra-fine¿ needle had a cannula too long.The following information was provided by the initial reporter : the consumer stated that the needle of the insulin syringes from the ultra-fine 3/10 ml is too long and too thick and hurt during injection.The consumer does not re-use.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 11/19/2021 h.6.Investigation: customer returned a total of 10 0.3ml syringes with no packaging for lot confirmation.The returned samples were inspected to ensure that using them was as least harmful as intended.The outer diameters of the syringe needles were measured, the results of which are featured below: 1.0.0123 in 2.0.0123 in 3.0.0124 in 4.0.0124 in 5.0.0123 in 6.0.0123 in 7.0.0123 in 8.0.0124 in 9.0.0122 in 10.0.0123 in all of the needles were measured within acceptable outer diameters for 30 gauge needles (0.0120 in to 0.0125 in).The length of each needle was measured and all were found to be within acceptable parameters for 12.7mm needles.The integrity of each needle point was inspected and no defects were found.No debris was found at the tip of any of the needles.Lastly, flour was applied to the needles¿ cannulas to ensure that lubricant was present.Sufficient lubricant was found on all samples.No damage to the needles of any kind was observed.The needles were within specifications and did not feature any dullness or burrs.A review of the device history record was completed for batch # 0055954 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of incorrect needle dimensions.The root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.
 
Event Description
It was reported that 1 bd insulin syringes with bd ultra-fine¿ needle had a cannula too long.The following information was provided by the initial reporter : the consumer stated that the needle of the insulin syringes from the ultra-fine 3/10 ml is too long and too thick and hurt during injection.The consumer does not re-use.Date of event : unknown samples : available.
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12845364
MDR Text Key281027842
Report Number1920898-2021-01213
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328431
Device Lot Number0055954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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