ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-KS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-10-06 for ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-KS manufactured by Arrow Intl., Inc..

Event Text Entries

[19374090] A visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation. A device history record review was performed on the stimucath with no relevant findings. A corrective action is not required at this time as the potential root cause could not be determined based on the info provided and without a sample. Complaint verification testing could not be performed because no sample was returned for analysis. The device history records for the stimucath were reviewed with no evidence of suggest a mfg related cause. The potential cause of a catheter leak could not be determined based on the info provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10


[19401369] The event is reported as: the customer alleges that the catheter had a pin hole size leak located outside of the patient's body. The catheter was removed and there was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036844-2014-00404
MDR Report Key4152522
Report Source05,06,07
Date Received2014-10-06
Date of Report2014-09-17
Date of Event2014-09-12
Date Mfgr Received2014-09-17
Device Manufacturer Date2014-03-01
Date Added to Maude2014-10-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1ARROW INTL., INC.
Manufacturer Street312 COMMERCE PL.
Manufacturer CityASHEBORO NC 27203
Manufacturer CountryUS
Manufacturer Postal Code27203
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW CONTINUOUS NERVE BLOCK KIT
Generic NameANESTHESIA CONDUCTION KIT
Product CodeOGJ
Date Received2014-10-06
Catalog NumberAB-19608-KS
Lot Number23F14C0764
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTL., INC.
Manufacturer AddressREADING PA 19605 US 19605


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-06

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