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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 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 328468
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(4). Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for dimension and hyperglycemia on lot # 9322380. A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, dimension and hyperglycemia) was captured and addressed appropriately. Investigation summary: customer returned five (5) loose 31gx8mm, 0. 5ml bd insulin syringes. Consumer reported getting higher glucose readings due to the change of the needle size. All five returned syringes were examined, then tested for cannula length and outer diameter. The following was observed (specs: outer diameter for 31g cannula: 0. 0100¿- 0. 0105¿): data: cannula length outer diameter (in. ) sample 1 good 0. 0101. Sample 2 good 0. 0101. Sample 3 good 0. 0102. Sample 4 good 0. 0102. Sample 5 good 0. 0102. All five syringes tested within specification. Next, all five syringes were tested for flow: all five syringes were able to draw and expel properly. No evidence of manufacturing defect was observed. Since no defects were observed the alleged issues could not be confirmed. A review of the device history record was completed for batch# 9322380. All inspections and challenges were performed per the applicable operations qc specifications. There was one (1) notification [200862180] noted that did not pertain to the complaint. Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that high glucose readings were found after changing the needle size of the bd insulin syringe with the bd ultra-fine¿ needle. This was discovered after use. The following information was provided by the initial reporter: material no: 328468 batch no: 9322380. It was reported getting higher glucose readings due to the change of the needle size. Verbatim: consumer reported claims switched to this size 3 weeks ago and now getting higher glucose test. Was using the 12. 7mm. Has not seen doctor advised consumer to do so. Glucose values with 12. 7 avg 140-160 with 8mm getting 240.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
Type of DevicePISTON SYRINGE
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
8015652341
MDR Report Key10237763
MDR Text Key199256748
Report Number1920898-2020-00793
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908468039
UDI-Public00382908468039
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 Other Health Care Professional
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328468
Device Catalogue Number328468
Device Lot Number9322380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
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: 07/06/2020 Patient Sequence Number: 1
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