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

Catalog Number 2000E CHINA

Device Problem Backflow (1064)

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

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter e-mail: unknown.2000e china 510k: this is an international code: the model#/catalog# identified in section d4 is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is 2000e.The 510k number provided is for the domestic similar product: k960280.Investigation summary: a 2000e china product was not available for investigation; however, the customer indicated the complaint sample is from lot 22026146.The feedback provided by the customer indicates the smartsite allowed blood to backflow; however no further information was provided by the customer to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 222026146 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.Please note that the 2000e china does not contain a back check valve and therefore during use it may be possible for back flow to occur under certain infusion rates and clinical set-ups.When the smartsite component is accessed with a compatible male luer, it is effectively an open path, through which fluid can travel in both directions; however, when the connecting product is removed, it becomes a closed system.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 2000e china product over the past 12 months.

Event Description

Cw 12/28 it was reported that blood backflowed into the main chamber of the bd smartsite¿ needle-free connector during the infusion.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, after the replacement of the deep vein indwelling tube, a new bd needle-free closed infusion joint was used in the main and side cavities of the patient for injection of liquid medicine.There was blood return in the main chamber, but there was no blood return in the side chamber.After replacing the side chamber bd needle-free closed infusion joint, there was blood return again.Considering that the abnormal needle-free infusion joint caused no blood return, it was judged that there was a quality problem in the bd needle-free closed infusion joint.No harm was caused to the patient.".

• Brand Name: BD 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
• 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: 15581217
• MDR Text Key: 306692600
• Report Number: 9616066-2022-01514
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403238345
• UDI-Public: (01)10885403238345
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K960280
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 22026146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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