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U.S. Department of Health and Human Services


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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), usa 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. Case 2: in (b)(6) 2018, a female researcher received an accidental needlestick injury while recapping a needle after inoculating a mouse with the uganda zika virus strain mr766 at a concentration of 107 pfu/ml (6). At the time of the incident, she was working in a biosafety cabinet and was double gloved. She felt the stick from the needle on her left middle finger but did not see any blood. She immediately removed her gloves, washed her hands with soap and water, and applied alcohol. After 10 days, she became symptomatic with a pruritic maculopapular rash, arthralgia, and myalgia. Zika virus infection was confirmed on the basis of the detection of zika virus rna in urine and serologic testing. There was no reported local zika virus transmission where she lived, and apart from the needlestick injury she had no other risk factors for acquisition of zika virus infection. She recovered completely within ¿2 weeks of symptom onset.
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Type of DeviceSYRINGE
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
MDR Report Key12197295
MDR Text Key262474888
Report Number2243072-2021-01924
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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