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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 320468
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: a complaint lot history check was performed on lot # 0041226 for needle hub separates. This is the 1st related complaint for needle hub separates on lot # 0041226. A review of risk management 150rmn-0001-16 revision 14 indicates that the potential risk of this specific reported incident (syringe, unable to perform function) was captured and addressed. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch# 0041226. All inspections and challenges were performed per the applicable operations qc specifications. There were two (2) notifications [200878340] noted that did not pertain to the complaint. There was one (1) notification [200878718] noted for out of spec shield pull as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Based on the above, no additional investigation and no capa/sa is required at this time.
 
Event Description
It was reported that the bd ultra-fine ii¿ insulin syringe was damaged and didn't have the cap attached. The following information was provided by the initial reporter: "i'm just writing about a syringe i had in a box the cap wasn't attached or usable. The lot number on the bag is 0041226 y. ".
 
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Brand NameBD ULTRA-FINE II INSULIN SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11418363
MDR Text Key251446050
Report Number1920898-2021-00267
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number320468
Device Lot Number0041226
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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