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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE Back to Search Results
Catalog Number 324909
Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Patient Problems Peeling (1999); Burning Sensation (2146); Caustic/Chemical Burns (2549); Chemical Exposure (2570)
Event Date 09/03/2019
Event Type  Injury  
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 foreign matter occurred before use with a syringe 0. 3 ml 31ga 6 mm whole unit 10bag. The following information was provided by the initial reporter, "hello, item arrived damaged with a chemical substance on the outside of the box that seeped through damaging the contents inside. Upon opening the package the chemical substance burnt the superficial layer of an employee's hand. Customer disposition request: replacement. Per e-mail attached : lot 9028788, no medical intervention, date of incident (b)(6) 2019. I am concerned that shipping the package would be hazardous due to the substance found on the package. After less than 30 seconds of opening the package i noticed my hand tingling. Immediately i put it under cool water and cleansed it, and noticed it had started peeling the top layers of the skin. We have a doctor on premises and he took a look at my hand agreed that people should not touch it and to handle it with gloves. I immediately contacted medline but it was after normal business hours for them and they asked call back the following day. I sent an email that night and called back and they said to put the package aside and wait. ".
 
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Brand NameSYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
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 Key9126270
MDR Text Key165956882
Report Number1920898-2019-01045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
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 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number324909
Device Lot Number9028788
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 Received09/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2019
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: 09/26/2019 Patient Sequence Number: 1
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