MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

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.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• 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 Key: 12197438
• MDR Text Key: 262484139
• Report Number: 2243072-2021-01926
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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 Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other