MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E-04

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

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.(b)(4).

Event Description

It was reported that the smartsite needle-free connector could not be primed due to an occlusion in the line.The following information was provided by the initial reporter: "unable to prime the smartsite with saline.Posiflush was connected correctly but was unable to be primed due to a likely occlusion.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/23/2020.H.6.Investigation: two 2000e-04 samples were received for investigation; one from lot 20076686 in sealed packaging and one from lot 20075484 in opened packaging.A visual inspection of the samples did not identify any signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by separately connecting each sample to a 50ml bd plastipak syringe from stock; no flow restriction or occlusion was observed throughout testing.A review of the production records for lots 20075484 and 20076686 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.H3 other text : see h.10.

Event Description

It was reported that the smartsite needle-free connector could not be primed due to an occlusion in the line.The following information was provided by the initial reporter: "unable to prime the smartsite with saline.Posiflush was connected correctly but was unable to be primed due to a likely occlusion".

• Brand Name: SMARTSITE NEEDLE-FREE CONNECTOR
• 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 22244 ; MX 22244
• MDR Report Key: 11088794
• MDR Text Key: 250329813
• Report Number: 9616066-2020-20666
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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
• Device Operator: Other
• Device Expiration Date: 07/08/2023
• Device Catalogue Number: 2000E-04
• Device Lot Number: 20075484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1