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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Viral Infection (2248); Needle Stick/Puncture (2462)
Event Date 06/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. The customer's address is unknown. (b)(6) has been used as a default. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that there was a needle stick injury while using unspecified bd" syringe. The following information was provided by the initial reporter: it was reported by the literature article that a needle stick injury occurred. Relevant article text: in (b)(6) 2016, a female researcher who worked in a biosafety level (bsl) 3 microbiology laboratory sustained a needlestick injury with a bifurcated needle; information on whether the skin was punctured was not available. The incident occurred during in vitro inoculation of human skin cells with wild-type zika virus for vaccine research purposes. She was wearing 2 pairs of nitrile gloves and working in a biosafety cabinet. She immediately used a surgical sponge and chlorohexidine to scrub the wound for 15 minutes, then washed her hands with soap and water. After 9 days, she experienced a low-grade fever, generalized maculopapular rash, headache, myalgia, and fatigue; mild unilateral conjunctivitis occurred the next day. She did not live in an area with local zika virus transmission, and in the month before illness onset she had no other risk factors for acquisition of zika virus infection (i. E. , no history of travel, no sexual contact with a traveler, and no history of blood transfusion or organ transplantation). She reported full resolution of her symptoms within 5 days. Zika virus infection was confirmed through the detection of zika virus rna in serum and urine and zika virus igm and neutralizing antibodies in serum.
 
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Brand NameUNSPECIFIED BD SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12197438
MDR Text Key262484139
Report Number2243072-2021-01926
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/20/2021 Patient Sequence Number: 1
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