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Adverse Event Report

ABBOTT LABORATORIES SAFESET W/TWO PORTS 60' TUBING PRESSURE MONITORING KIT   back to search results
Catalog Number 42644
Device Problem Overdelivery
Event Date 01/26/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Report rec'd of "freeflow" of intravenous fluid during priming of a pressure monitoring kit. The nurse opened the monitoring kit and exchanged the vented caps for non-vented caps. All the luer connections were tightened and checked. When the iv container of 0. 9% normal saline was spiked to prime the tubing, the line reportedly "freeflowed" and immediately filled with iv solution. The nurse re-checked the luer connections and found them to be secure. It was reported that no abnormalities were seen in the montioring kit. A new kit was opened and readied for pt use. There were no delays in treatment associated with the malfunction. Though requested, no add'l info was provided.

 
Manufacturer Narrative

The device is expected to be returned for investigation. It has not yet been rec'd.

 
Search Alerts/Recalls

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Brand NameSAFESET W/TWO PORTS 60' TUBING
Type of DevicePRESSURE MONITORING KIT
Baseline Brand NameSAFESET W/TWO PORTS 60' TUBING
Baseline Generic NamePRESSURE MONITORING KIT
Baseline Catalogue Number42644
Baseline Device FamilyMONITOR, BP, TRANSDUCER, NON-INDWELLING
Baseline Device 510(K) NumberK932188
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed06/01/1994
Manufacturer (Section F)
ABBOTT LABORATORIES
4455 atherton
salt lake city UT 84123
Manufacturer (Section D)
ABBOTT LABORATORIES
4455 atherton
salt lake city UT 84123
Manufacturer (Section G)
ABBOTT LABORATORIES
4455 atherton
salt lake city UT 84123
Manufacturer Contact
thomas sampogna, assoc dir
200 abbott park rd
dept. 389, bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key516200
MDR Report Key527036
Event Key500285
Report Number1713468-2004-00006
Device Sequence Number1
Product CodeDRS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/29/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number42644
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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