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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
Catalog Number 328468
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Event Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle hub separated and remained in the shield.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "needle hub separated and stayed inside of the shield.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 18-jul-2022.H.6.Investigation summary: customer returned one syringe in a polybag labeled for 0.5ml, 8mm, 31 gauge syringes from lot 9343403, and two loose syringes.The syringe from lot 9343403 had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.The remaining syringes were returned fully intact outside of both polybags.A needle shield pull force test was performed on each of these syringes.The needle shields required 2.28 lbs and 1.97 lb of force to be removed.Removing the needle shields found that the hubs were properly attached to the barrel of the syringes.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.No defects found to these two syringes.A review of the device history record was completed for batch# 9343403.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of needle hub separation.A definitive root cause cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle hub separated and remained in the shield.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "needle hub separated and stayed inside of the shield.".
 
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Brand Name
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15014306
MDR Text Key301248665
Report Number1920898-2022-00449
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328468
Device Lot Number9343403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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