MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GRAVITY V/NV CKV 2SS 15D DEHP-FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 10053857

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's address is unknown:  new jersey (nj), usa has been used as a default.  investigation summary: the customer reported the tubing came apart at the drip chamber during priming, and returned a photo of the incident.The picture clearly shows separation below the drip chamber, and the complaint is verified.A device history record review for model 10053857 lot number 21069699 was performed.(b)(4).There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The physical sample was not able to be returned and the root cause is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 bd gravity v/nv ckv 2ss 15d dehp-free experienced component separation.The following information was provided by the initial reporter: we had an incident regarding the use of the bd smartsite gravity infusion set.On two separate occasions today with two separate nurses, the bd smartsite gravity set malfunctioned.Both nurses primed their solution bags and soon after hanging the bags on the pole, the tubing came apart at the chamber connection site.The first bag caused an expense waste and the second was just normal saline.

• Brand Name: BD GRAVITY V/NV CKV 2SS 15D 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: 12912919
• MDR Text Key: 284989219
• Report Number: 9616066-2021-52512
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234123
• UDI-Public: 50885403234123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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
• 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: Other
• Device Model Number: 10053857
• Device Catalogue Number: 10053857
• Device Lot Number: 21069699
• 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: 06/15/2021
• 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