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

Model Number 41173E

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

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

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¿ gravity set iv line was blocked and caused reflux during the infusion.The following information was provided by the initial reporter: "we found that the 41173e was causing reflux and clotting off our iv lines.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the 41173e was causing reflux and clotting off our iv lines.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 41173e because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that the bd alaris¿ smartsite¿ gravity set iv line was blocked and caused reflux during the infusion.The following information was provided by the initial reporter: "we found that the 41173e was causing reflux and clotting off our iv lines".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: 12626001
• MDR Text Key: 276382891
• Report Number: 9616066-2021-52215
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020900
• UDI-Public: 37613203020900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 41173E
• Device Catalogue Number: 41173E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2021
• 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