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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 0.3ML 31GX5/16" INSULIN SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16" INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328440
Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/26/2017
Event Type  malfunction  
Manufacturer Narrative
The date of event is unknown. The date received by the manufacturer is used. Medical device expiration date: this device does not have an expiration date. (b)(4). Device evaluation: a sample is available for evaluation. A supplemental report will be filed upon completion of the investigation.
 
Event Description
It was reported the shield of several syringes was hard to remove and felt tighter than normal. The customer removed the shield with his teeth, jabbing his finger on the unused needle in the process. Although he reports his finger hurts, he did not seek medical attention.
 
Manufacturer Narrative
Device evaluation: result - a review of the device history record was completed for the reported lot # 6137620. All inspections and challenges were performed per the applicable operations qc specifications. This lot was packaged 10jul2016 to 12jul2016. The customer returned (10) 3/10cc, 8mm, 31g syringes in a sealed poly bag from lot # 6137620. All returned syringes were tested to determine the shield removal forces (specs: shield removal force for 3/10cc after sterilization: 0. 85-5. 95 lbs. ). All removal forces fall within specifications. Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure. An absolute root cause for this incident was not determined.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16"
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 Key6341070
MDR Text Key68050904
Report Number1920898-2017-00019
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 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328440
Device Lot Number6137620
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 Manufactured05/16/2016
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: 02/17/2017 Patient Sequence Number: 1
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