NEEDLE SPINAL S/SU 18GA 6IN QUINCKE 408360

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-04 for NEEDLE SPINAL S/SU 18GA 6IN QUINCKE 408360 manufactured by Bd Caribe Ltd..

Event Text Entries

[179110803] There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8123805, medical device expiration date: 2023-05-31, device manufacture date: 2018-07-02. Medical device lot #: 9088609, medical device expiration date: 2024-03-31, device manufacture date: 2019-05-29. Pma/510(k)#: preamendment. 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


[179110804] It was reported that an unspecified number of needle spinal s/su 18ga 6in quincke experienced product damage/deformation -device still operable, and were involved in a serious injury in the form of medical intervention. During treatment, a portion of the device became embedded within the patient's kidney and had to be removed by a health care professional. No additional information regarding the outcome of this medical intervention has been specified. The following information was provided by the initial reporter: the device in question is: aig pl 150mm 18g 408360, ref: 408360 and number of series: 8123805 and 9088609. The problem encountered is: "during an nlpc (nephrolithotomy per cutaneous) use of the spinal needle to locate the kidney. Smaller needle diameter at the end of the needle impeding the passage of the guide that "spins" and can't remove the guide. " clinical consequences: "rupture of part of the guide wire in the patient's kidney. This part had to be recovered. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2618282-2020-00004
MDR Report Key9667274
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-02-04
Date of Report2020-03-19
Date of Event2019-12-18
Date Mfgr Received2020-01-15
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone8015652341
Manufacturer G1BD CARIBE LTD.
Manufacturer StreetROAD 31 K.M. 24.3
Manufacturer CityJUNCOS
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEEDLE SPINAL S/SU 18GA 6IN QUINCKE
Generic NameANESTHESIA CONDUCTION NEEDLE
Product CodeBSP
Date Received2020-02-04
Model Number408360
Catalog Number408360
Lot NumberSEE H.10
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD CARIBE LTD.
Manufacturer AddressROAD 31 K.M. 24.3 JUNCOS US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.