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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE LL BNS CONVENTIONAL SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE LL BNS CONVENTIONAL SYRINGE Back to Search Results
Catalog Number 301031
Device Problem Structural Problem (2506)
Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946)
Event Date 03/01/2019
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 bd¿ syringe ll bns had a sharp edge on the flange, leaded to a technician getting cut through the glove. The syringe had been exposed to blood, so this technician would go through a year of follow-up testing for the possible exposure to the patients bodily fluid. Customer¿s verbatim: "deroyal has received a complaint on a part that you provide to us as vender; syringe 20cc l/l, deroyal part # 5-20057, catalog # 301031, lot # 8269986. It was reported that there was a sharp edge on the flange of the syringe that lead to a technician getting cut through the glove. This technician will now require follow up testing for a year. This complaint is in ra status and if the investigation could be expedited that would be appreciated. A sample is available for return and should arrive by tomorrow. I will send you a photo once it arrives. ".
 
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Brand NameBD¿ SYRINGE LL BNS
Type of DeviceCONVENTIONAL SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8441330
MDR Text Key139541328
Report Number1911916-2019-00298
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301031
Device Lot Number8269986
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 Received03/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2018
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: 03/21/2019 Patient Sequence Number: 1
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