ARROW 00815357 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-30 for ARROW 00815357 * manufactured by Arrow Intl..

Event Text Entries

[122952] 1/3/98: during placement of port-a-cath at the cephalosubclavian route, the surgeon noticed a foreign body catheter in the superior vena cave. X-ray report confirmed the presence of the foreign body catheter. 4/7/98: removal of foreign body catheter. 1/7/98: x-ray demonstrated successful removal of foreign body catheter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number146706
MDR Report Key146706
Date Received1998-01-30
Date of Report1998-01-19
Date of Event1998-01-03
Date Added to Maude1998-02-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameARROW
Generic NameSLIC-SINGLE LUMEN INFUSION CATHETER
Product CodeJCY
Date Received1998-01-30
Model Number00815357
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key142979
ManufacturerARROW INTL.
Manufacturer Address2400 BERNVILLE RD READING PA 19605 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-01-30

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