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
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9616066-2021-52512
• Device Sequence Number: 20072651
• Product Code: FPA
• UDI-Device Identifier: 50885403234123
• UDI-Public: 50885403234123
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/15/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown