ANGEL WING 23G BCS W/LUER ADPTR 8881225307

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-27 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 manufactured by Tyco/kendall Healthcare.

Event Text Entries

[403693] It was reported to tyco/kendall healthcare that a customer had a problem with the angel wing blood collection system. The customer states that the needle came disconnected from the hub and remained stuck in the vein of the pt. They were able to remove the needle from the pt. Samples are being returned for examination.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2006-00011
MDR Report Key680866
Report Source06
Date Received2006-02-27
Date of Report2006-02-21
Date of Event2006-01-27
Date Reported to Mfgr2006-02-21
Date Mfgr Received2006-02-21
Date Added to Maude2006-03-03
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 ContactADRIENNE MARCELLUS, RN
Manufacturer Street15 HAMPSHIRE ST
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082618441
Manufacturer G1TYCO/KENDALL HEALTHCARE
Manufacturer Street2498 ROLL DR #727
Manufacturer CitySAN DIEGO CA 92154
Manufacturer CountryUS
Manufacturer Postal Code92154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGEL WING 23G BCS W/LUER ADPTR
Generic NameBLOOD COLLECTION
Product CodeGJE
Date Received2006-02-27
Model Number8881225307
Catalog Number8881225307
Lot Number5315528
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key670137
ManufacturerTYCO/KENDALL HEALTHCARE
Manufacturer Address2498 ROLL DR # 727 SAN DIEGO CA 92154 US
Baseline Brand NameMONOJECT
Baseline Generic NameBLOOD COLLECTION SET
Baseline Model No8881225307
Baseline Device FamilySAFETY BLOOD COLLECTION SETS AND ACCESSORIES
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK940961
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2006-02-27

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