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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 328440
Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
It was reported that 3 bd insulin syringes with bd ultra-fine¿ needles had damaged product and operational issues.The following information was provided by the initial reporter : the consumer reported 3 syringes with multiple issues of broken syringe, hub, barrel and plunger rod, not able to draw up insulin, a pin sized hole in the barrel and insulin sprayed out the hole.Date of event : unknown, sample status : awaiting sample.
 
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 01-mar-2022.H6: investigation summary: customer returned a single 0.3ml syringe with no other identification.The syringe appeared undamaged.Functional testing was performed on the syringe.The syringe was capable of drawing, holding, and expelling the water.The syringe was returned undamaged and functioned as intended.A review of the device history record was completed for batch # 1228476 all inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200977255, 200977243] noted that did not pertain to the complaint.There was one (1) notification [200977258] noted for cracked barrel.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of the barrel being broken damaged.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of hub damage.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of the syringe not drawing.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of a hole in the barrel.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of leakage.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
Event Description
It was reported that 3 bd insulin syringes with bd ultra-fine¿ needles had damaged product and operational issues.The following information was provided by the initial reporter : the consumer reported 3 syringes with multiple issues of broken syringe, hub, barrel and plunger rod, not able to draw up insulin, a pin sized hole in the barrel and insulin sprayed out the hole.Date of event : unknown.Sample status : awaiting sample.
 
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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 Key13591050
MDR Text Key286055993
Report Number1920898-2022-00123
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 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328440
Device Lot Number1228476
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
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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