MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number MX9128

Device Problem Component Misassembled (4004)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

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 maxguard administration set with needleless y-site(s) was built upside down.The following information was provided by the initial reporter: this set was built upside down.

Manufacturer Narrative

H6: investigation summary: one photo was provided for quality investigation.The customer complaint for misassembly was verified by visual inspection.Evaluation of the infusion set in the photo, shows that the smartsite was installed backwards.A device history record review for model mx9128 lot number 22029810 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22feb2022.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 failure seen in this complaint is an error at the manufacturing facility installing the component incorrectly into the assembly.Further investigation at the manufacturing facility identified the root cause a failure to use an assembly fixture during the construction of the infusion set.

Event Description

It was reported that the bd maxguard administration set with needleless y-site(s) was built upside down.The following information was provided by the initial reporter: this set was built upside down.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
• 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: 14437877
• MDR Text Key: 292071794
• Report Number: 9616066-2022-00626
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403237629
• UDI-Public: 50885403237629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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: 06/15/2022

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: MX9128
• Device Catalogue Number: MX9128
• Device Lot Number: 22029810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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