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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE

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BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 05/28/2020
Event Type  Injury  
Manufacturer Narrative
]date of event: unknown. The date received by manufacturer has been used for this field. ]medical device expiration date: unknown. The customer's address is unknown. (b)(6) usa has been used as a default. Device manufacture date: unknown a device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). 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.
 
Event Description
It was reported that an unspecified bd insulin syringe had a serious medical impact. No further information could be obtained. The following information was provided by the initial reporter: "it was reported that consumer stated his spouse was going to die. Consumer husband reported to a bd associate at the nassc that his wife was going to die from using the bd products. The bd associate attempted to transfer the caller to bd com but was unsuccessful in doing so. Bd associate was unable to obtain the callers information before transfer. Caller was belligerent and cursive. Lot #: unknown we will not be able to obtain this information. Catalog#: unknown we will not be able to obtain this information. Date of event: unknown we will not be able to obtain this information. Samples status no samples. ".
 
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Brand NameUNSPECIFIED BD INSULIN SYRINGE
Type of DeviceINSULIN 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10171692
MDR Text Key199989798
Report Number2243072-2020-00929
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 consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
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 Received05/28/2020
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: 06/18/2020 Patient Sequence Number: 1
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