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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE Back to Search Results
Catalog Number 328506
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Event Date 06/27/2019
Event Type  malfunction  
Manufacturer Narrative
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 that four syringes 1. 0 ml 31ga 8 mm 10bag 500 wal caused an allergic reaction after use. The following information was provided by the initial reporter: material no. : 328506. Batch no. : 8190574. Complaint 2 of 2: date of occurrence (b)(6) 2019. Verbatim: consumer stated: after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy". It happened on (b)(6) 2019. 4 syringes were used. No medication or follow up visits necessary and she wipes the needle with a alcohol swab before use. Stated once the itching stops and redness goes away, a bruise is left behind.
 
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Brand NameSYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
Type of DevicePISTON 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
8015652341
MDR Report Key8787180
MDR Text Key150990261
Report Number1920898-2019-00659
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328506
Device Lot Number8190574
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2018
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: 07/12/2019 Patient Sequence Number: 1
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