FDA Adverse Event Injury Summary report: N

ARROW

MDR report key: 3613 · Received December 29, 1992

Report

Report Number
3613
Event Type
Injury
Date Received
December 29, 1992
Date of Event
December 1, 1992
Report Date
December 9, 1992
Manufacturer
AROW INTERNATIONAL
Product Code
DXG
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

AS THE NURSE CUT THE SUTURE HOLDING THE PATIENT'S A-LINE IN PLACE HE NOTED PULSATING BLOOD AT THE RIGHT RADIAL ARTERY SITE. AS THE A-LINE CATHETER WS REMOVED IT WAS OBSERVED TO BE SHORTER THAN USUAL. AN X-RAY OF THE PATIENT'S RIGHT HAND REVEALED A RETAINED PORTION OF CATHETER. A 11/2" PIECE OF CATHETER WAS REMOVED SURGICALLY. THE PATIENT IS IN STABLE CONDITIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER, OTHER. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARROW RADIAL ARTERY CATHERIZATION SET DXG AROW INTERNATIONAL UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 73 YR Required Intervention