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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 324910
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Unspecified Infection (1930)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A device history review was not conducted because a lot number could not be determined. Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.
 
Event Description
It was reported that there was a painful injection while using a bd insulin syringe with bd ultra-fine¿ needle, and the injection site became ¿reddish and infected afterwards¿. There was reported use of antibiotic ointment after event. There was no report of medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE WITH NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7182594
MDR Text Key96983513
Report Number1920898-2017-00427
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number324910
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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