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 Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

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 in section g5 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 was from lot 22025316.The feedback provided by the customer indicates leakage was detected from a "broken" smartsite component.No further information was available 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 22025316 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.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite component in the past 12 months.

Event Description

It was reported that the bd smartsite¿ needle-free connector's positive pressure joint was cracked and leaked during use.The following information was provided by the initial reporter, translated from chinese: "during use, it was found that the positive pressure joint was broken and leaked." "confirmed by the hospital equipment department, the incident occurred in the department of respiratory medicine.After communication with the head nurse of the department, according to the head nurse's description, the joint rupture site is the white end of 2000e joint, and the rupture degree is crack.The joint has been indwelled for 2 days and cracks appear.".

• 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: 15407639
• MDR Text Key: 306162193
• Report Number: 9616066-2022-01322
• Device Sequence Number: 1
• Product Code: FPA
• 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: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 22025316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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