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

Catalog Number 30842E-0006

Device Problem Failure to Deliver (2338)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd extension set there was a clog.There was no report of patient impact.The following information was provided by the initial reporter: the issue/concern: a patient receiving an insulin infusion using the extension set.Clinical staff have found that the insulin was not being delivered.Clinical staff have ruled out what the issue was and found that it was the extension set stopping the insulin to be infused.Apparently, similar incidences happened in other departments but nil reports were raised to procurement.

Event Description

It was reported while using bd extension set there was a clog.There was no report of patient impact.The following information was provided by the initial reporter: the issue/concern: a patient receiving an insulin infusion using the extension set.Clinical staff have found that the insulin was not being delivered.Clinical staff have ruled out what the issue was and found that it was the extension set stopping the insulin to be infused.Apparently, similar incidences happened in other departments but nil reports were raised to procurement.

Manufacturer Narrative

Investigation summary: a 30842e-0006 sample was not available for investigation; furthermore, the lot number was not provided in this instance.The feedback provided by the customer suggests an occlusion was detected during use of the extension set; however, no further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.

• Brand Name: BD 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 ; 8448235433
• MDR Report Key: 16740444
• MDR Text Key: 313318887
• Report Number: 9616066-2023-00687
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020283
• UDI-Public: (01)37613203020283
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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: Other
• Device Catalogue Number: 30842E-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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