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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 328440
Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)
Patient Problems Purulent Discharge (1812); Rash (2033)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform dhr due to unknown lot number. Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
 
Event Description
It was reported with the use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with scale marking error, plunger rod difficult to move and patients developed red bumps and some puss. The doctor treated the patients with doxycycline to help or a medrol-dose pack.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceSYRINGE 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 Key7818173
MDR Text Key118287427
Report Number1920898-2018-00665
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328440
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
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: 08/27/2018 Patient Sequence Number: 1
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