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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAV SET 20DP V/NV W/CKV 3SS 104-IN INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAV SET 20DP V/NV W/CKV 3SS 104-IN INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 42493E
Device Problems Component Missing (2306); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a complaint of a missing roller clamp was received from the customer. A sample was provided to aid in the investigation of this defect. Through visual inspection, the customer complaint was verified. The roller clamp was not assembled with the set. A device history record review for model 42493e lot number 21029646 was performed. The search showed that a total of 14,403 units in 1 lot number was built on 18feb2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. The root cause for this defect is an assembly error during the manufacturing of this set. This incident has been added to our database of reported incidents.
 
Event Description
It was reported that a grav set 20dp v/nv w/ckv 3ss 104-in had a missing roller clamp before use. The following was reported by the initial reporter: "there's no roller clamp it came missing".
 
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Brand NameGRAV SET 20DP V/NV W/CKV 3SS 104-IN
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 Key11881108
MDR Text Key263545847
Report Number9616066-2021-51141
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K820278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42493E
Device Catalogue Number42493E
Device Lot Number21029646
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2021
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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