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Adverse Event Report

ABBOTT LABORATORIES VENTED SET PRM IV W/OL ADMINISTRATION SET   back to search results
Catalog Number 11553
Device Problem Rupture
Event Date 08/01/2003
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Report received of a tubing rupture during power injection. It was reported that contrast media was being injected through the y-site on the primary set at 150cc over 2-2. 5 seconds for an unspecified ct study. It was reported that 25-50cc of contrast media had been injected when the tubing ruptured at an unspecified location. Contrast media reportedly splashed across the pt's arm but not on the face. The iv site was not lost and there was no blood loss. The problem was resolved by changing the tubing, re-injecting the contrast media, and resuming the ct study. The customer reported that there were no adverse pt effects. Though requested, no add'l info was provided.

 
Manufacturer Narrative

Samples were received in 2003. Testing and investigation are not complete.

 
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Brand NameVENTED SET PRM IV W/OL
Type of DeviceADMINISTRATION SET
Baseline Brand NameVENTED SET PRM IV W/OL
Baseline Generic NameADMINISTRATION SET
Baseline Catalogue Number11553
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ABBOTT LABORATORIES
p.o. box 212-3006
barreal de heredia
COSTA RICA
Manufacturer (Section D)
ABBOTT LABORATORIES
p.o. box 212-3006
barreal de heredia
COSTA RICA
Manufacturer (Section G)
ABBOTT LABORATORIES
p.o. box 212-3006
barreal de heredia
COSTA RICA
Manufacturer Contact
thomas sampogna associate direct
200 abbott park road
dept. 389 bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key476095
MDR Report Key487206
Event Key461914
Report Number9615050-2003-00187
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/08/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11553
Device LOT Number050125H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2003
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

Patient TREATMENT DATA
Date Received: 09/29/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,1)MEDRAD CT INJECTOR
MED RAD INC, MANUFACTURER,,
2,2)ISOVUE 300
AMERSHAM HEALTH, MANUFACTURER,

Database last updated on January 30, 2009

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