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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA
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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA Back to Search Results
Catalog Number 324902
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem Reaction (2414)
Event Date 08/13/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that syringe 1.0ml 31ga 6mm u40 10bag india plunger was difficult to move.This occurred on 10 occasions during use.The following information was provided by the initial reporter: there is a wound at insulin injection site, which developed because of hardness of insulin injection plunger.And now the wound is healing slowly.
 
Manufacturer Narrative
H.6.Investigation: no samples were returned as of 16 october 2020 therefore the investigation was performed based on the photos provided.Three (3) photos regarding the reported issue with 1ml bd insulin syringes from lot 9231170 were provided.Consumer reported there is a wound at insulin injection site, which developed because of hardness of insulin injection plunger, and now the wound is healing slowly.All 3 provided photos were reviewed, and no evidence of a defect could not be determined from the photos alone.Since no issues were observed the alleged issue could not be confirmed.A review of the device history record was completed for batch# 9231170.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200842457] noted that did not pertain to the complaint.There was one (1) notification [200841002] noted for out of spec breakout and sustaining.
 
Event Description
It was reported that syringe 1.0ml 31ga 6mm u40 10bag india plunger was difficult to move.This occurred on 10 occasions during use.The following information was provided by the initial reporter: there is a wound at insulin injection site, which developed because of hardness of insulin injection plunger.And now the wound is healing slowly.
 
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Brand Name
SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key10485042
MDR Text Key205466476
Report Number1920898-2020-01156
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number324902
Device Lot Number9231170
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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