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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 Problem Failure to Deliver (2338)
Patient Problem Hypoglycemia (1912)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the syringe 1. 0ml 31ga 6mm u40 10 bag, (b)(6), experienced insufficient cannula length, and was involved with the lay user/patient experiencing hypoglycemia. It has not been specified whether medical intervention, or additional dosage was administered as a result of the hypoglycemia. The following information was provided by the initial reporter: consumer stated, his number's have been really low. Stated, the pharmacy gave him u-40 syringes to use for insulin injections; stated, has not seen doctor for low number; stated, since he stopped using the u-40 syringes, his numbers have been normal again. Stated that he should have received, 31g, 3/10ml, 6mm. Lot: 7072869; catalog: 324902; date of event: unknown.
 
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Brand NameSYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA
Type of DeviceSYRINGE
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
8015296192
MDR Report Key10840935
MDR Text Key216313729
Report Number1920898-2020-01568
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324902
Device Lot Number7072869
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2017
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: 11/13/2020 Patient Sequence Number: 1
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