FDA Adverse Event Summary report: N

VACUTAINER, PRECISION GLIDE

MDR report key: 21292 · Received February 7, 1994

Report

Report Number: 21292
Date Received: February 7, 1994
Date of Event: July 18, 1993
Report Date: January 31, 1994
Manufacturer: BECTON DICKINSON AND COMPANY
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

JULY 18, 1993: WHILE DRAWING A BLOOD SPECIMEN FROM A PTIENT, THE RN REMOVED THE FIRST BLOOD COLLECTION TUBE. THIS ALLOWED BLOOD TO SPLASH FROM THE END OF THE VACUTAINER ONTO THE RN'S ARM, ABOVE THE GLOVED/PROTECTED AREA. THE RN DID HAVE PARTIALLY HEALED SCRATCHES ON THIS AREA OF THE ARM. THE PATIENT IS HIV POSITIVE, CURRENTLY DIAGNOSISED AND IN TREATMENT FOR AIDS. UPON EXAMINATION, THE VACUTAINER DID NOT HAVE A RUBBER SHEATH TO PREVENT BLOOD LEADAGE FROM THE PORT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VACUTAINER, PRECISION GLIDE			BECTON DICKINSON AND COMPANY	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Invalid Data