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

Catalog Number	ME1225
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard¿ extension set was blocked at the filter during the infusion.The following information was provided by the initial reporter: "we have been experiencing infusion related issues with the following bd 1.2 micron tubing sets.Nursing is experiencing issues with the medication not being able to proceed past the filter in the line.We are now on option 3 as presented by the bd rep and we are still experiencing the same issue.What we have tried so far.Ref # (b)(4), ref # (b)(4), ref# (b)(4) (currently using).We have not reached out to bd with the current issue we are experiencing but we have sent off products when using the first product".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxguard¿ extension set was blocked at the filter during the infusion.The following information was provided by the initial reporter: "we have been experiencing infusion related issues with the following bd 1.2 micron tubing sets.Nursing is experiencing issues with the medication not being able to proceed past the filter in the line.We are now on option 3 as presented by the bd rep and we are still experiencing the same issue.What we have tried so far ref # (b)(4).Ref # (b)(4).Ref# (b)(4).We have not reached out to bd with the current issue we are experiencing but we have sent off products when using the first product".
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.It was reported by the customer that they are experiencing issues with the medication not being able to proceed past the filter in the line.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model me1225 because a invalid lot number was provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXGUARD¿ EXTENSION SET
• Common Device Name: 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: 16625032
• Report Number: 9616066-2023-00575
• Device Sequence Number: 11890100
• Product Code: FPA
• UDI-Device Identifier: 10885403236129
• UDI-Public: 10885403236129
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: ME1225
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown