ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2 ASK-20608-ROP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-11 for ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2 ASK-20608-ROP manufactured by Arrow Intl., Inc..

Event Text Entries

[23433170] (b)(4). A visual, functional and dimensional inspection could not be performed as no sample was returned for analysis. No lot number was provided. A device history record review was performed based on a lot number from sales history. A device history record review was performed on the catheter and needle with no relevant findings. The ifu for this product was reviewed as a part of this complaint investigation. The ifu for this product states "use extreme care to never adjust position of the needle while catheter tip is still advanced beyond tip of needle. " if the catheter is retracted against the needle bevel, it can lead the catheter to shear as the customer reported. A corrective action is not required at this time as the potential cause of difficulty threading the catheter could not be determined based upon the info provided and without the sample. Complaint verification testing could not be performed as no sample was returned for analysis. The potential cause of difficulty threading the catheter through the needle could not be determined based upon the info provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10


[23433171] A customer alleges having difficulty in removing the needle and stylet. The catheter sheared and had to be restarted. No pt injury reported. Procedure - total knee replacement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036844-2015-00323
MDR Report Key4999158
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-08-11
Date of Report2015-07-17
Date of Event2015-07-16
Date Mfgr Received2015-07-17
Date Added to Maude2015-08-13
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 ContactMARGIE BURTON, RN
Manufacturer Street3015 CARRINGTON MILL BLVD.
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
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 Report0

Device Details

Brand NameARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2
Generic NameANESTHESIA CONDUCTION KIT
Product CodeOGJ
Date Received2015-08-11
Catalog NumberASK-20608-ROP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTL., INC.
Manufacturer AddressREADING PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-11

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