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

Catalog Number	MZ5307
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the unspecified bd maxzero extension set experienced flow issues.The following information was provided by the initial reporter: there was blood reflux after the administration of drugs by simple descent, and doubts arose regarding the change of the needle-free connectors, which are already included in the extension.
Event or Problem Description
It was reported that the bd maxzero¿ extension set experienced flow issues.The following information was provided by the initial reporter: there was blood reflux after the administration of drugs by simple descent, and doubts arose regarding the change of the needle-free connectors, which are already included in the extension.
Additional Manufacturer Narrative
B.5.Describe event or problem: it was reported that the bd maxzero¿ extension set experienced flow issues.The following information was provided by the initial reporter: there was blood reflux after the administration of drugs by simple descent, and doubts arose regarding the change of the needle-free connectors, which are already included in the extension.D.1.Medical device brand name: bd maxzero¿ extension set.D.2.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.4.Medical device catalog #: mz5307.D.4.Medical device lot #: 21096362.D.4.Medical device expiration date: 2024-09-29.D.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma/510(k)#: k140831.H.4.Device manufacture date: 2021-09-28.H.6 investigation summary: a mz5307 product was not available for investigation; however, the customer indicated the complaint sample was from lot 21096362.The feedback provided by the customer indicates the bd maxzero extenders were trialled in the hospital by the nurses as a replacement for the currently used kdl extenders, during the trial the customer confirms that they experienced backflow of blood after the administration of drugs.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21096362 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as a sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.Please note that maxzero valves are not back check valves and are not designed to prevent back flow when connected to another infusion set.Furthermore as stated in the directions for use of the maxzero valve "flush the maxzero after each use with normal saline or in accordance with facility protocol.Failure to properly prime the device can result in reflux." a review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz5307 product in the past 12 months.

• 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 NJ 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14651673
• Report Number: 2243072-2022-00789
• Device Sequence Number: 5693894
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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 Expiration Date: 09/29/2024
• Device Catalogue Number: MZ5307
• Device Lot Number: 21096362
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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