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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 328512
Device Problems Partial Blockage (1065); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter :   the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
Date of event: unknown.Medical device expiration date : unknown.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: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 1/6/2022 h.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g syringe in an open poly bag from lot # 0160001.Customer states that the needle wiill not draw, plunger rod appeared to be blocked and bounced back while drawing.The returned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0160001.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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 syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter :   the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown samples : available.
 
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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 Key13157642
MDR Text Key284386532
Report Number1920898-2021-01359
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 01/13/2022
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 Number328512
Device Lot Number0160001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received01/04/2022
Supplement Dates Manufacturer Received01/13/2022
Supplement Dates FDA Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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