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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE FINE II¿ BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM INSULIN SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE FINE II¿ BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328289
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 01/26/2017
Event Type  Injury  
Manufacturer Narrative
The date of event is unknown. The date received by the manufacturer is used. (b)(4), medical device expiration date: this device does not have an expiration date. Device evaluation: it is unknown if a sample is available for evaluation. A supplemental report will be filed upon completion of the investigation.
 
Event Description
The customer reports that when she injects into both her arm and abdomen, white bumps appear. When she pushes on the site, a white substance comes out. The customer states she visited the doctor 4 years ago but "did not look at the site". She also visited a dermatologist who performed a biopsy to the site but they "didn't see anything". The customer will be visiting her doctor and will ask again about the issue as she is still getting white bumps at times. The customer has been injecting for 10 years, states she rotates injection sites, and denies reuse.
 
Manufacturer Narrative
Device evaluation the customer returned (10) 1cc, 8mm, 31g syringes in a sealed poly bag from lot # 6144763. All returned syringes were tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0. 0100¿-0. 0105¿). All observations fall within specifications. A review of the device history record was completed for lot #6144763. All inspections and challenges were performed per the applicable operations qc specifications. Based on the samples, bd was not able to duplicate or confirm the customer¿s indicated failure.
 
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Brand NameFINE II¿ BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM
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 Key6335909
MDR Text Key67579681
Report Number1920898-2017-00023
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 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328289
Device Lot Number6144763
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 Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2017 Patient Sequence Number: 1
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