BD INSTRUMENT SEDI-40 361546

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for BD INSTRUMENT SEDI-40 361546 manufactured by Becton Dickinson.

Event Text Entries

[94987191] 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. Medical device expiration date: unknown. Device manufacture date: unknown. Results: bd received 1 instrument returned from the customer facility for investigation. The returned unit was returned to the manufacturer for service, and it was observed that the tube cover was broken. The cover was replaced by the manufacturer and returned to the customer. Conclusion: based on the investigation, a root cause could not be determined within the scope of this evaluation. Bd was able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10


[94987192] It was reported that the bd instrument sedi-40 tube cover was broken. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2017-00367
MDR Report Key7100309
Date Received2017-12-08
Date of Report2017-11-21
Date of Event2017-06-07
Date Mfgr Received2017-06-07
Date Added to Maude2017-12-08
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 INSTRUMENT SEDI-40
Generic NameSEDIMENTION INSTRUMENT
Product CodeGHC
Date Received2017-12-08
Returned To Mfg2017-07-19
Catalog Number361546
Lot NumberUNKNOWN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON
Manufacturer Address1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-12-08

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