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

Model Number 10802688

Device Problem Component Missing (2306)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris smartsite gravity set there were missing components.There was no report of patient impact.The following information was provided by the initial reporter: mohawk medbuy (plexxus) has logged this issue/complaint internally in our system - your mohawk medbuy (plexxus) reference numbers are (b)(4).Please note that the manufacturer/supplier may request additional details and for the product to be return for investigation, if required.Incident date (b)(6) 2023.Device part# smartsite gravity administration set 10802688.Lot /serial # (b)(4).Expiry date: 2025-10-18.Issue description quality complaint ¿ broken/damage (out of box) did not occur during patient use.2 tubing ¿ no roller clamp.2 tubing ¿ came apart at fluid chamber.Occurrences 2.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review for model 10802688 lot number 22109302 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h10.

Event Description

It was reported while using bd alaris smartsite gravity set there were missing components.There was no report of patient impact.The following information was provided by the initial reporter: mohawk medbuy (plexxus) has logged this issue/complaint internally in our system - your mohawk medbuy (plexxus) reference numbers are (b)(4).Please note that the manufacturer/supplier may request additional details and for the product to be return for investigation, if required.Incident date 15may2023 ¿ 18may2023 device part# smartsite gravity administration set 10802688 lot /serial # (b)(6) expiry date: 2025-10-18 issue description quality complaint ¿ broken/damage (out of box) did not occur during patient use.2 tubing ¿ no roller clamp 2 tubing ¿ came apart at fluid chamber occurrences 2.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17101790
• MDR Text Key: 317156471
• Report Number: 9616066-2023-01149
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234437
• UDI-Public: (01)50885403234437
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K820278
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10802688
• Device Catalogue Number: 10802688
• Device Lot Number: 22109302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2022
• 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