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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 Fever (1858); Vomiting (2144); Chills (2191)
Event Date 07/19/2021
Event Type  Injury  
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. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Material number and batch number is unknown; a lot history review could not be performed. 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. Capa is not required at this time.
 
Event Description
It was reported that unspecified bd¿ syringe was used and the patient experienced vomiting, rigoring, temperature of 36. 0, and a post washback fever of 39. 5. The following information was provided by the initial reporter: we have had a small number of patients in the last few weeks who have had rigors and/or fever towards the end of their haemodialysis/apheresis session or just after disconnection. All patients affected have central venous catheters. Cultures and infection screens are reported negative. "halfway through session vomit and rigoring++, temp 36. 0, post washback fever 39. 5. ".
 
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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 Key12351688
MDR Text Key267634331
Report Number2243072-2021-02152
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
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 Received07/23/2021
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: 08/20/2021 Patient Sequence Number: 1
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