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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; SYRINGE, ANTISTICK

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BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; SYRINGE, ANTISTICK Back to Search Results
Catalog Number 305934
Device Problem Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult/unable to operate (not drawing) on lot # 9200478.This is an mds product, risks, hazards and harms are captured under the umbrella of risk management document (b)(4).Investigation summary: customer returned (1) 1/2ml, 8mm, 30g bd safetyglide insulin syringe from lot # 9200478.Customer states that it is unable to draw medication.The retuned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 9200478.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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 1/2 ml bd safetyglide¿ insulin syringe with attached needle was unable to aspirate during use.The following information was provided by the initial reporter: unable to draw medicine.No deformation or damage in appearance.
 
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Brand Name
1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
Type of Device
SYRINGE, ANTISTICK
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 Key10610378
MDR Text Key209638810
Report Number1920898-2020-01329
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number305934
Device Lot Number9200478
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2020
Initial Date FDA Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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