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

Catalog Number 42519E

Device Problem Component Missing (2306)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 2 bd alaris¿ smartsite¿ gravity sets were missing their roller clamps.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.Two are missing the roller clamps".

Manufacturer Narrative

Investigation summary: three samples were submitted for quality investigation.The customer complaint of misassembly was verified by visual inspection.Two of samples that were submitted did not have the roller clamp on the assembly.A device history record review for model 42519e lot number 22059085 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the missing roller clamps is a failure at the manufacturing facility during the assembly of the infusion set.An investigation was conducted at the manufacturing facility and it was determined that the missing roller clamp was caused because the correct fixture was not used during the assembly of the infusion set.

Event Description

It was reported that 2 bd alaris¿ smartsite¿ gravity sets were missing their roller clamps.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.Two are missing the roller clamps.".

• 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 ; 8015296192
• MDR Report Key: 16319132
• MDR Text Key: 309042799
• Report Number: 9616066-2023-00143
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203010870
• UDI-Public: 07613203010870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 42519E
• Device Lot Number: 22059085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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