MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP SS BAG 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10015862

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem Chemical Exposure (2570)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ lvp ss bag 20d low sorb fell out of the iv port and exposing nurses to drug residue.The following information was provided by the initial reporter: this is in regard to 250 ml sodium chloride 0.9% iv bags.We have had recent incidents of bag spikes (administration sets for bd alaris pumps) falling out of the iv port and exposing nurses to drug residue.Nurses were splashed with drug residue upon different incidents of drug administration.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of bag spikes falling out of the iv port could not be verified due to the product not being returned for failure investigation.Device history record review for model 10015862 lot number 22075926 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.

Event Description

It was reported that the bd alaris¿ lvp ss bag 20d low sorb fell out of the iv port and exposing nurses to drug residue.The following information was provided by the initial reporter: ¿this is in regard to 250 ml sodium chloride 0.9% iv bags.We have had recent incidents of bag spikes (administration sets for bd alaris pumps) falling out of the iv port and exposing nurses to drug residue.Nurses were splashed with drug residue upon different incidents of drug administration.

• Brand Name: BD ALARIS¿ LVP SS BAG 20D LOW SORB
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16065574
• MDR Text Key: 308485188
• Report Number: 9616066-2022-02088
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10015862
• Device Lot Number: 22075926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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