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

Catalog Number	MZX5305
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero¿ extension set, standard bore, pressure rated, 1 bonded maxzero¿ needle-free connector, 1 max y-site, 1 white slide clamp, spin male luer lock tubing separated from the locking collar when attaching to the patient resulting in blood back-up and iv restart.The following information was provided by the initial reporter: iv access device malfunction - starting a new peripheral iv on pt., placed and threaded catheter and retracted needle, when hooking up extension tubing hub to end of iv catheter, swiveled attachment fell off from the tubing, leaving the iv patent and backing up with blood onto bedding.Since no tubing and clamp to stop bleeding, iv pulled and restarted with a new set up.1.Was there any harm or injury to the patient, health care provider, or any other person? yes ¿ additional need to start another line 2.Was there a delay of or change in the course of treatment due to the event? please provide any available details.Yes ¿ additional need to start another line 3.If not answered in question #2, what was the medication administered to the patient? unknown.
Additional 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.
Event or Problem Description
It was reported that bd maxzero¿ extension set, standard bore, pressure rated, 1 bonded maxzero¿ needle-free connector, 1 max y-site, 1 white slide clamp, spin male luer lock tubing separated from the locking collar when attaching to the patient resulting in blood back-up and iv restart.The following information was provided by the initial reporter: iv access device malfunction - starting a new peripheral iv on pt., placed and threaded catheter and retracted needle, when hooking up extension tubing hub to end of iv catheter, swiveled attachment fell off from the tubing, leaving the iv patent and backing up with blood onto bedding.Since no tubing and clamp to stop bleeding, iv pulled and restarted with a new set up.1.Was there any harm or injury to the patient, health care provider, or any other person? yes ¿ additional need to start another line.2.Was there a delay of or change in the course of treatment due to the event? please provide any available details.Yes ¿ additional need to start another line.3.If not answered in question #2, what was the medication administered to the patient? unknown.
Additional Manufacturer Narrative
H6: investigation summary: one photo of a new set provided from customer and have placed highlights to explain issue.It was reported by customer that iv access device malfunction - starting a new peripheral iv on pt, placed and threaded catheter and retracted needle, when hooking up extension tubing hub to end of iv catheter, swiveled attachment fell off from the tubing, leaving the iv patent and backing up with blood onto bedding.A device history record review could not be performed because a lot number was not provided by the customer.Picture of new similar sample set could not verify the complaint.Actual sample is needed to perform testing under magnification.Due to no actual sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD MAXZERO¿ 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17479416
• Report Number: 9616066-2023-01669
• Device Sequence Number: 16815975
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: MZX5305
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/18/2023
• 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