ARROW IPN040139 EC-05000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for ARROW IPN040139 EC-05000 manufactured by Teleflex Incorporated.

Event Text Entries

[176245575] There was 2 catheters which are defective; one was bent and the second one shredded. Per the doctor's operative note: preop diagnosis: cervical radiculopathy. Postop diagnosis: cervical radiculopathy. Procedure planned: epidural steroid injection at the c7-t1 interspace, fluoroscopic guidance. The site of pain and procedure were confirmed prior to starting the procedure. The target interspace was identified. The skin overlying the target area was prepped with chlorhexidine and sterilely draped. Local anesthesia was obtained with 3. 0 ml of preservative free 1% lidocaine. Using a 20-gauge tuohy needle with a loss-of-resistance to normal saline and hanging drop technique, the epidural space was located. Aspiration was negative for blood or csf. Subsequently 1 ml of lopamidol 240m contrast was injected demonstrating appropriate epidural spread. Local anesthetic test dose was negative for intrathecal injection. 10mg dexamethasone was suspended in 4ml of preservative free normal saline was easily injected into the epidural space without apparent complication. The tuohy needle was then cleared with preservative free 1% lidocaine and removed. The skin was cleansed and the patient returned to the supine position. The patient was stable throughout the procedure. Epidural spread was observed up to about c5 level based on contrast, catheter was not inserted although this was initially planned given difficulties experienced with the arrow catheter kit. The patient was observed following the procedure and was then discharged in stable condition with a driver. The patient received post-procedure discharge instructions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9626891
MDR Report Key9626891
Date Received2020-01-24
Date of Report2020-01-08
Date of Event2019-12-18
Report Date2020-01-08
Date Reported to FDA2020-01-08
Date Reported to Mfgr2020-01-24
Date Added to Maude2020-01-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW
Generic NameANESTHESIA CONDUCTION KIT
Product CodeCAZ
Date Received2020-01-24
Model NumberIPN040139
Catalog NumberEC-05000
Lot Number13F18C0518
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX INCORPORATED
Manufacturer AddressPO BOX 12600 DURHAM NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-24

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