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

Catalog Number MX4436

Device Problem Component Missing (2306)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H3.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 bd maxguard extension set with needleless y-site(s), stopcock(s) and manifold tubing clamp was missing.The following information was received by the initial reporter with the verbatim: reported issue: the roller clamp on the tubing was not present.

Event Description

It was reported that bd maxguard extension set with needleless y-site(s), stopcock(s) and manifold tubing clamp was missing.The following information was received by the initial reporter with the verbatim: reported issue: the roller clamp on the tubing was not present.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-sep-2023.H6: investigation summary a complaint of a set missing a roller clamp was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The set was assembled without a roller clamp.A device history record review for model mx4436 lot number 22119025 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and a review of the manufacturing process was completed.After investigation, the potential root cause of missing roller clamp could be related to the assembler not using the fixture due to it being damaged/inverted.A work order ((b)(4)) was released to carry out an inspection of fixtures to identify the damages and fix them.A quality alert was also created and communicated to the production personnel to reinforce the escalation process and notify when a fixture is damaged.

• Brand Name: BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795499
• MDR Text Key: 324028709
• Report Number: 9616066-2023-01927
• Device Sequence Number: 1
• Product Code: FPA
• 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: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX4436
• Device Lot Number: 22119025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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