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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE PISTON SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 07/15/2021
Event Type  Death  
Manufacturer Narrative
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. Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Date of event: unknown. The date received by manufacturer has been used for this field. Date of death: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. The customer's address is unknown. Unknown, (b)(6) usa has been used as a default. Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4). Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the unspecified bd¿ syringe was used to administer the pfizer vaccine, which caused the patient to have an allergic reaction, including a rash and fainting. They were taken to the hospital, were they recovered after an unspecified amount of time. However, "after a month or so" of receiving the vaccine, the patient passed away. No further information has been received. The following information was provided by the initial reporter: "'i had a friend that died 2 weeks ago after receiving the covid vaccine. They are going to search for the cause of death (autopsy) because after the vaccine she had a rash, fainted, went to the hospital, she recovered. But after a month or so (uncertain) she passed away. ' caller says the woman was born a very unhealthy person. 'i cannot tell you even the name, i never met her, she is a niece of a friend of mine. '".
 
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Brand NameUNSPECIFIED BD SYRINGE
Type of DevicePISTON 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 Key12321915
MDR Text Key266614350
Report Number2243072-2021-02070
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
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 Received07/15/2021
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: 08/13/2021 Patient Sequence Number: 1
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