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

Model Number 10010511

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set stopcock leaked while measuring the opening pressure.The following information was provided by the initial reporter: "customer states when the doctors go to measure opening pressure, the 3way stopcock was leaking.".

Manufacturer Narrative

H6: investigation summary: no photos or samples were received with the customer's complaint of leakage.Without any info/ physical sample to investigate, the complaint cannot be verified and the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set stopcock leaked while measuring the opening pressure.The following information was provided by the initial reporter: "customer states when the doctors go to measure opening pressure, the 3way stopcock was leaking.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• 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: 12682723
• MDR Text Key: 278111317
• Report Number: 9616066-2021-52294
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233478
• UDI-Public: 50885403233478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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: Health Professional
• Device Model Number: 10010511
• Device Catalogue Number: 10010511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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