FDA Adverse Event Malfunction Summary report: N

SHARPS CONTAINER DISPOSABLE

MDR report key: 1401 · Received September 22, 1992

Report

Report Number: 1401
Event Type: Malfunction
Date Received: September 22, 1992
Date of Event: August 16, 1992
Report Date: August 28, 1992
Manufacturer: SAGE PRODUCTS, INC.
Product Code: KPE
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

NEEDLE PUNCTURE FROM DISPOSABLE SHARPS BOX CONTAINER OCCURRED ON 8/16/92. THE LPN WHO SUSTAINED THE NEEDLE PUNCTURE NOTIFIED THE INFECTION CONTROL NURSE OF THE INCIDENT. THE LPN PLACED RIGHT PALM AGAINST BOX AS SHE DISPOSED OF NEEDLE/SYRINGE. A NEEDLE INSIDE THE CONTAINER PROTRUDED THROUGH PUNCTURING THE RIGHT PALM OF LPN. THE LPN WILL REQUIRE 6 WEEK/3MONTH/6MONTH BLOOD TEST FOLLOW UP. LAB TESTS PERFORMED ON EMPLOYEE INCLUDE HBSAG AND ANTI-HBS. NEEDLE PROTRUDED THROUGH CONTAINER APPROXIMATELY 3/4 FROM BOTTOM NEAR CENTERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: .INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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, OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SHARPS CONTAINER DISPOSABLE	N/A	KPE	SAGE PRODUCTS, INC.	8966-1	8970-E

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR		Other