MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20019E7D

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd y ext w/vlv ports & 2 sld clp leaked and had blood backflow during infusion. The following information was provided by the initial reporter: "after administering the medication there is a backflow of blood and fluid coming out from the smartsite extension adapter. ".

Manufacturer Narrative

Investigation summary: a 20019e7d product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21075725. From the information provided by the customer it appears that backflow of blood occurred from the patient, and leakage was observed from the smartsite. As part of the feedback the customer provided a video of the affected smartsites; analysis of the video confirmed the customer's experience as leakage was observed from the piston of the smartsite. Further information provided by the customer also indicates that the smartsite was oval in shape. The details of this feedback were forwarded to the manufacturing site for investigation. A review of the production records for lot 21075725 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. Please note, the root cause of the oval shape is exposure of the smartsite to an external heat source that brings the component temperature above 60°c. The piston head of the smartsite is oval shaped therefore when the round fla component is placed over it, the piston opening is squeezed shut in order to create a seal. Under excessive heat conditions, the fla material can soften, and as the piston pushes back on the inside, it can reshape the fla to conform to the original oval shape of the piston head. Previous investigations have not found a potential root cause for this level of excess heat as a result of any stage of the manufacturing or sterilization processes at the manufacturing site. A review of the customer feedback database indicates that there is no increased trend for oval smartsite valves. It is possible that there is a local environmental factor that has caused the product to reach the elevated temperature required to cause this issue (e. G. During storage or transit).

• Brand Name: BD Y EXT W/VLV PORTS & 2 SLD CLP
• 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: 12929769
• MDR Text Key: 284985875
• Report Number: 9616066-2021-52537
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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: 11/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 20019E7D
• Device Lot Number: 21075725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial