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

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.

• Brand Name: BD GEM 20D V/NV NTG .2MF 1SS DEHP FREE
• Type of Device: INTRAVASCULAR 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 Key: 12907931
• MDR Text Key: 286116275
• Report Number: 9616066-2021-52508
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203015814
• UDI-Public: 37613203015814
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: 10010454
• Device Catalogue Number: 10010454
• Device Lot Number: 20095932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1