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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 328438
Device Problem Volume Accuracy Problem (1675)
Patient Problems Underdose (2542); Insufficient Information (4580)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8351989, medical device expiration date: 2024-01-31, device manufacture date: 2018-12-17, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the scale markings were off.Patient (cat) was not able to get correct amount of medication.The following information was provided by the initial reporter: it was reported that scale markings are off and feels like she miss-dosed her cat.
 
Event Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the scale markings were off.Patient (cat) was not able to get correct amount of medication.The following information was provided by the initial reporter: it was reported that scale markings are off and feels like she miss-dosed her cat.
 
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# 8351989.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification noted for smoky barrels.There was one (1) notifications notification noted that did not pertain to the complaint.Dhr could not be reviewed on the unknown lot number.
 
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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
MDR Report Key11152687
MDR Text Key231426847
Report Number1920898-2021-00020
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328438
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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