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

Catalog Number 2000E7D

Device Problem Difficult to Remove (1528)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: first name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd smartsiteâ¿¢ needle-free valve experienced difficult disconnection from the device.The following information was provided by the initial reporter, translated from portugese: when used for the administration of indovenous medicines, in which a simple equipment or infusion pump equipment is used, when disconnecting from the device, it presents pressure which prevents it from being removed.It is necessary to disconnect the catheter sealing device to attempt to remove it, which ends "opening" the system, which can occur blood chain infection.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 17-nov-2022.Investigation summary : one 2000e7d sample from lot 1022883 was received in sealed packaging for investigation in which the customer has reported experiencing difficulty separating the smartsite product from an unknown catheter.No sample of the catheter product was received to aid the investigation.Further details relating to the nature of the reported issue and the clinical set up, including details of the catheter product to which the 2000e7d product was connected, were not provided to aid the investigation.The customer did provide two photographs, however, these only show a side view of the smartsite component and its associated packaging.Examination of the sample found no damage or deformity which might explain the customer's experience.In order to try to replicate the issue reported by the customer, the 2000e7d sample was connected to various other products from bd stock; no connection issues were encountered, in each instance the connection between the products was secure, but it was also possible to separate the products when required.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 1022883 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no defective products were provided for examination and testing of the returned unused sample did not identify any product defects that could have contributed to the customer¿s experience.

Event Description

It was reported that the bd smartsite¿ needle-free valve experienced difficult disconnection from the device.The following information was provided by the initial reporter, translated from portugese: when used for the administration of indovenous medicines, in which a simple equipment or infusion pump equipment is used, when disconnecting from the device, it presents pressure which prevents it from being removed.It is necessary to disconnect the catheter sealing device to attempt to remove it, which ends "opening" the system, which can occur blood chain infection.

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE VALVE
• 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: 15601252
• MDR Text Key: 306806652
• Report Number: 9616066-2022-01539
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1022883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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