MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX4450
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd 64" (163 cm) stdbore ext set w/two 4-way there was a blockage.This is 2 of 2 related reports.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the tubing cannot be flushed or primed.New complaint to be generated- captures sets for dates of events (b)(6) and 2 unknown dates.
Event or Problem Description
It was reported, while using bd 64" (163 cm) stdbore ext set w/two 4-way.There was a blockage.This is 2 of 2 related reports.There was no report of patient impact.The following information was provided by the initial reporter: it was reported, by the customer.That the tubing cannot be flushed or primed new complaint to be generated, captures sets for dates of events 4/7.And 2 unknown dates.
Additional Manufacturer Narrative
The following fields were updated, due to additional information: d10: device available for eval? yes, d10: returned to manufacturer on: 24-apr-2023.H6: investigation summary: three sample, model mx4450 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe and unable to be flushed.Visual inspection under the microscope showed, signs of excess solvent near the female luer.A quality notification was sent to the manufacturer.From the manufacturers investigation.Operator did not follow, the procedure mfg0225 for mdgn dispenser.And insert multiple the tube into solvent dispenser.A quality alert was generated on 29jun203 to prevent this defect.No corrective/preventive actions were taken on this investigation, since the controls to prevent occlusion in tubing were in place.A device history record review could not be performed, because a lot number was not provided by the customer.

• Brand Name: BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY
• 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: 16829604
• Report Number: 9616066-2023-00771
• Device Sequence Number: 7125241
• Product Code: FPA
• UDI-Device Identifier: 50885403274679
• UDI-Public: (01)50885403274679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/17/2023

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: Other
• Device Model Number: MX4450
• Device Catalogue Number: MX4450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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