BD MAGNI-GUIDE? INSULIN SYRINGE MAGNIFIER 328233

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for BD MAGNI-GUIDE? INSULIN SYRINGE MAGNIFIER 328233 manufactured by Becton Dickinson.

Event Text Entries

[128257732] Oem manufacturer: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. 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 event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[128257733] It was reported that the bd magni-guide? Insulin syringe magnifier cracked after use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2018-01655
MDR Report Key8096849
Date Received2018-11-21
Date of Report2018-11-30
Date of Event2018-11-05
Date Mfgr Received2018-11-05
Device Manufacturer Date2016-09-28
Date Added to Maude2018-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652845
Manufacturer G1BECTON DICKINSON
Manufacturer Street1 BECTON DRIVE
Manufacturer CityFRANKLIN LAKES NJ 07417
Manufacturer CountryUS
Manufacturer Postal Code07417
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD MAGNI-GUIDE? INSULIN SYRINGE MAGNIFIER
Generic NameMAGNIFIER, HAND-HELD, LOW-VISION
Product CodeHJF
Date Received2018-11-21
Catalog Number328233
Lot Number19637213
OperatorLAY USER/PATIENT
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON
Manufacturer Address1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-21

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