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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 928856
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  malfunction  
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.
 
Event Description
It was reported by a consumer there was difficult plunger movement while using a bd¿ insulin syringe with needle; specifically, during injection "she pushes really hard on plunger and nothing comes out." there was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
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# 7240676.All inspections were performed per the applicable operations qc specifications.There were five notifications noted that did not pertain to the complaint.Based on the samples / photo(s) 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.
 
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Brand Name
BD¿ INSULIN SYRINGE WITH NEEDLE
Type of Device
INSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7612228
MDR Text Key111856056
Report Number1920898-2018-00418
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00311917048130
UDI-Public00311917048130
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2022
Device Catalogue Number928856
Device Lot Number7240676
Initial Date Manufacturer Received 05/25/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received05/25/2018
Supplement Dates FDA Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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