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

Catalog Number	MZ5305
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 22089402.D4.Medical device expiration date: 27-aug-2025.H4.Device manufacture date: 19-aug-2022.D4.Medical device lot #: 23049168.D4.Medical device expiration date: 27-aug-2025.H4.Device manufacture date: 13-apr-2023.H3.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 while using he bd maxzero¿ extension set that the luers (screw-on hub) are unable to loosen to attach to catheter hub, and are causing leaking at the connection to the catheter.The following was received from the initial reporter: verbatim: luer (screw-on hub) is sticking/unable to loosen to attach to catheter hub, not long enough to cover internal extension, not securing properly and is causing leaking at the connection to the catheter.
Event or Problem Description
It was reported while using he bd maxzero¿ extension set that the luers (screw-on hub) are unable to loosen to attach to catheter hub, and are causing leaking at the connection to the catheter.The following was received from the initial reporter: verbatim: luer (screw-on hub) is sticking/unable to loosen to attach to catheter hub, not long enough to cover internal extension, not securing properly and is causing leaking at the connection to the catheter.
Additional Manufacturer Narrative
Investigation summary: two photos were provided by the customer regarding the reported failure.The customer complaint of component damage - leak could not be verified by the photos submitted.A device history record review for model mz5305 lot numbers 22089402 and 23049168 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17224301
• Report Number: 9616066-2023-01312
• Device Sequence Number: 6970072
• Product Code: FPA
• UDI-Device Identifier: 00382903051564
• UDI-Public: 00382903051564
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: MZ5305
• Device Lot Number: SEE H.10
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/31/2023
• 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