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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 42521E
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the gra 15dp ckv 3ss w/2 4w stpck dehp free experienced component separation, and leakage. The following information was provided by the initial reporter: standard bd smartsite gravity iv set have defective stopcocks that will not tighten. They are used as the standard iv srt oncold lines in the or. Despite tightening they will still become loose and cause potential harm to patient. On this specific event i had tightened the stopcocks prior to pushing induction medications. They appeared to be securely tightened. We had prepped the l arm hiding the iv site and tubing in the same arm we were placing a large bore micro-puncture catheter. While placing the line (needle in arm), we noticed that the iv was dripping well despite there being a tourniquet on the arm. We then moved the drape and noticed the stopcocks had disconnected and intravenous fluid and approximately 100cc of patient's blood were lost from the iv set disconnection. There are many other instances, most don't get put into our qms system. I don't have the particular lot number but as i said it happens too frequently to be a one time manufacturing issue. There is some element of design which prevents the stopcocks from tightening.
 
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Brand NameGRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12339021
MDR Text Key267270171
Report Number9616066-2021-51825
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number42521E
Device Catalogue Number42521E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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