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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10010454
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Event Description
It was reported that the bd gem 20d v/nv ntg. 2mf 1ss dehp free experienced device damage while still considered operable. The following information was provided by the initial reporter: pt and picc checked at 2200, upon checking pt at 2300 noted tpn line to be broken and dripping onto floor. Checked picc and picc insitu, and iv tubing line had snapped at tpn filter. Lipids were y'd into line below the filter therefore lipids were still infusing into lumen. Line clamped and pump stopped. Another rn in to assist and primed d5. 9ns line, tpn lines removed and lines cleansed as per cvl protocol. New line with d5. 9ns connected and started. Red jr called to notify of event. Tpn put on hold for night.
 
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer. The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation. A device history record review for model 1001045, lot number 20095932 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 07sep2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. No product will be returned per customer. No investigation was performed.
 
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer. The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation. A device history record review for model 1001045, lot number 20095932 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 07sep2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. No product will be returned per customer. No investigation was performed.
 
Event Description
It was reported that the bd gem 20d v/nv ntg. 2mf 1ss dehp free experienced device damage while still considered operable. The following information was provided by the initial reporter: pt and picc checked at 2200, upon checking pt at 2300 noted tpn line to be broken and dripping onto floor. Checked picc and picc insitu, and iv tubing line had snapped at tpn filter. Lipids were y'd into line below the filter therefore lipids were still infusing into lumen. Line clamped and pump stopped. Another rn in to assist and primed d5. 9ns line, tpn lines removed and lines cleansed as per cvl protocol. New line with d5. 9ns connected and started. Red jr called to notify of event. Tpn put on hold for night.
 
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Brand NameBD GEM 20D V/NV NTG .2MF 1SS 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 Key12907931
MDR Text Key286116275
Report Number9616066-2021-52508
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203015814
UDI-Public37613203015814
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10010454
Device Catalogue Number10010454
Device Lot Number20095932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2020
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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