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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE

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BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Septic Shock (2068)
Event Date 09/10/2020
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. (b)(4). Medical device expiration date: unknown. The customer's address is unknown. (b)(6). Usa has been used as a default. The initial reporter also notified the fda on 1 june, 2020. Medwatch report # mw5094702 report source other: medwatch report. 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 (b)(4).
 
Event Description
It was reported that unspecified bd¿ posiflush syringe may have been recalled. This was discovered during use. The following information was provided by the initial reporter: material no. Unknown batch no. Unknown it was reported that customer may have used a recalled syringe. Event description per email states: patient was admitted to hospital with sepsis on (b)(6) 2019 her port was removed because of the staff infection. Patient may have had a bd posiflush sf saline flush syringe as part of a port dressing change kit from the recalled lot numbers affected by the voluntary recall from bd.
 
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Brand NameUNSPECIFIED BD POSIFLUSH 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10564297
MDR Text Key208235805
Report Number2243072-2020-01470
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
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 Received09/10/2020
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: 09/21/2020 Patient Sequence Number: 1
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