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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 INSULIN SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328466
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. "there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7198837, expiration date: n/a, manufacture date: 08/31/2017. Medical device lot #: 7016808, expiration date: n/a, manufacture date: 03/09/2017. 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 the bd insulin syringe with the bd ultra-fine¿ needle plunger rod was difficult to move before injection. Found during use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: no samples or photographs 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# 7198837. All inspections and challenges were performed per the applicable operations qc specifications. There were four (4) notifications noted that did not pertain to the complaint. A review of the device history record was completed for batch# 7016808. All inspections and challenges were performed per the applicable operations qc specifications. There were three (3) notifications noted that did not pertain to the defect. Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE AND 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 Key7616108
MDR Text Key111996735
Report Number1920898-2018-00416
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 consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328466
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
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: 06/19/2018 Patient Sequence Number: 1
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