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

Model Number MS3500-15

Device Problem Component Missing (2306)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported while using bd alaris secondary set the tubing clamp was missing.There was no report of patient impact.The following information was provided by the initial reporter: material#: ms3500-15.Batch#: 23049212 it was reported by customer that 2161-pc: secondary set opened and no clamp present on tubing line.Verbatim: 2161-pc: secondary set opened and no clamp present on tubing line - udi - (b)(4).

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a complaint of set missing clamp was received from the customer.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 ms3500-15 lot number 23049212 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 secondary set the tubing clamp was missing.There was no report of patient impact.The following information was provided by the initial reporter: material#: ms3500-15 batch#: 23049212.It was reported by customer that 2161-pc: secondary set opened and no clamp present on tubing line.Verbatim: 2161-pc: secondary set opened and no clamp present on tubing line - udi - (b)(4).

• Brand Name: BD ALARIS SECONDARY 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: 17259357
• MDR Text Key: 318556407
• Report Number: 9616066-2023-01353
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Device Lot Number: 23049212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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