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

Catalog Number	ME2017
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxguard¿ extension set tubing snapped in half and leaked during use.The following information was provided by the initial reporter: "syringe tubing snapped in half when rn went to place label on it.Syringe tubing already in line with morphine continuously infusing to patient.Patient had a 1 minute pause in their continuous morphine and required new tubing to be primed and reattached to lines." "did you experienced any leakage due to the reported failure? yes.Pump was paused immediately and no harm came to patient.".
Additional Manufacturer Narrative
One extension set was received and tested by our quality team.The separation was immediately apparent, and the complaint was verified.After visual analyses under microscope, the failure was found to be a lack of solvent applied to the tubing to female luer junction during production.The manufacturing team has been notified and they have issued a quality alert to eliminate further occurrences of this failure.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that the bd maxguard¿ extension set tubing snapped in half and leaked during use.The following information was provided by the initial reporter: "syringe tubing snapped in half when rn went to place label on it.Syringe tubing already in line with morphine continuously infusing to patient.Patient had a 1 minute pause in their continuous morphine and required new tubing to be primed and reattached to lines." "did you experienced any leakage due to the reported failure? yes.Pump was paused immediately and no harm came to patient.".

• 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 ; 8015296192
• MDR Report Key: 15366937
• Report Number: 9616066-2022-01286
• Device Sequence Number: 13852053
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/01/2022

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: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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