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

Model Number MZ5304

Device Problem Component Missing (2306)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that the bd maxzero¿ extension set was missing clamp.The following information was provided by the initial reporter: clamp not on tubing.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of clamp issues/damage related to clamp could not be verified due to the product not being returned for failure investigation a device history record review for model mz5304 lot number 22079100 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.

Event Description

It was reported that the bd maxzero¿ extension set was missing clamp.The following information was provided by the initial reporter: clamp not on tubing.

Event Description

It was reported that the bd maxzero¿ extension set was missing clamp.The following information was provided by the initial reporter: clamp not on tubing.

Manufacturer Narrative

The following fields were updated due to additional information: imdrf annex c grid: c1601.Imdrf annex d grid: d03.Investigation summary: one photo was provided by the customer.The customer complaint of clamp issues/damage was verified by visual inspection of the photo provided.Review of the photo provided shows that the extension set tubing was not placed through the clamp correctly.A device history record review for model mz5304 lot number 22079100 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 the physical sample not being received, investigation of the root cause for the misassembly can only be based on what can be seen from the photo provided.An investigation was conducted at the manufacturing facility and it was determined that root cause is attributed to the absence of a fixture to ensure the correct placement of the component.A quality alert was generated to assure correct assembly of the component and the option of adding an assembly fixture is being evaluated.

• Brand Name: BD MAXZERO¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15964827
• MDR Text Key: 308147762
• Report Number: 9616066-2022-01934
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230578
• UDI-Public: (01)10885403230578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• 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,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ5304
• Device Catalogue Number: MZ5304
• Device Lot Number: 22079100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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