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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 324918
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Manufacturer Narrative
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 4 bd insulin syringes with the bd ultra fine¿needles were unable to aspirate.The following information was provided by the initial reporter : the customer reported that in a 10 syringes properly sealed package, 4 are not drawing the insulin.
 
Manufacturer Narrative
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# 1081665.All inspections and challenges were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.
 
Event Description
It was reported that 4 bd insulin syringes with the bd ultra fine¿needles were unable to aspirate.The following information was provided by the initial reporter : the customer reported that in a 10 syringes properly sealed package, 4 are not drawing the insulin.
 
Event Description
It was reported that 4 bd insulin syringes with the bd ultra fine¿needles were unable to aspirate.The following information was provided by the initial reporter : the customer reported that in a 10 syringes properly sealed package, 4 are not drawing the insulin.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 21-jun-2022.H6: investigation summary: customer returned (4) loose 1cc, 6mm syringes.Customer states that the syringes are not pulling the insulin.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch # 1081665.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Ebecta 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.
 
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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 Key14134755
MDR Text Key289430343
Report Number1920898-2022-00239
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/21/2022
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 Lay User/Patient
Device Catalogue Number324918
Device Lot Number1081665
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received04/18/2022
Supplement Dates Manufacturer Received04/22/2022
06/21/2022
Supplement Dates FDA Received05/10/2022
07/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
Patient SexFemale
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