MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9275
Medical Device Problem Codes	Crack (1135); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
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.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector screw attachment was cracked and it disconnected from the line.The following information was provided by the initial reporter: patient has a dual lumen pediatric power picc.When i disconnected the quad fuse from the white port of the picc, which was running sorenson and lipids, the screw attachment at the end of the quad fuse had a crack in it and disconnected from the rest of the line.New quad fuse immediately primed and swapped out.Notified and showed charge nurse where line defect was.No leakage around the old quad fuse detected before it broke.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of damaged component - no leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector screw attachment was cracked and it disconnected from the line.The following information was provided by the initial reporter: patient has a dual lumen pediatric power picc.When i disconnected the quad fuse from the white port of the picc, which was running sorenson and lipids, the screw attachment at the end of the quad fuse had a crack in it and disconnected from the rest of the line.New quad fuse immediately primed and swapped out.Notified and showed charge nurse where line defect was.No leakage around the old quad fuse detected before it broke.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 16443472
• Report Number: 9616066-2023-00271
• Device Sequence Number: 5844338
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: (01)10885403240768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 03/09/2023

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 Catalogue Number: MZ9275
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/22/2023
• 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