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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE Back to Search Results
Catalog Number 324918
Device Problems Plunge (1462); Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation: customer returned (3) 1cc, 6mm, 31g syringes in an open poly bag from lot # 5243890. Customer states that when the medicine is applied to the subcutaneous tissue the plunger locks and it is necessary to apply too much force, generating pain in the patient. All returned syringes were tested and all were able to draw and expel without any observed defects. All samples were also tested for point geometry, lube, and cannula od. The following was observed (specs: outer diameter for 31g: 0. 0100¿-0. 0105¿): (b)(6). All observations fall within specifications. As per manufacturing, a review of the device history record was completed for batch# 5243890. All inspections were performed per the applicable operations qc specifications. There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint. Based on the samples / photo(s) received, the investigation 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. Based on the above, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that the plunger on a bd ultra-fine¿ insulin syringe is difficult to move and increased force is necessary to administer the medication. Customer states this is causing pain although there was no report of exposure, injury or medical interventions.
 
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Brand NameBD ULTRA-FINE¿ INSULIN SYRINGE
Type of DeviceINSULIN 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
8015652845
MDR Report Key7300625
MDR Text Key101390269
Report Number1920898-2018-00077
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number324918
Device Lot Number5243890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
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: 02/27/2018 Patient Sequence Number: 1
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