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	MZ9267
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd maxzero¿ multi-fuse extension set with needleless connector each from lots 21125635, 21115715, 21055457, and 21105940, as well as four separate, unspecified lots, had issues with leakage during use.The following information was provided by the initial reporter: "as just discussed, because our critical care areas had continuous leaking with bd set and filter mz9267 and 10011865, that resulted in product being pulled from those areas".
Additional Manufacturer Narrative
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 lot number is as follows: medical device lot #: 21125635; medical device expiration date: 09-dec-2024; device manufacture date: 08-dec-2021.Medical device lot #: 21115715; medical device expiration date: 16-nov-2024; device manufacture date: 09-nov-2021.Medical device lot #: 21055457; medical device expiration date: 13-may-2024; device manufacture date: 05-may-2021.Medical device lot #: 21105940; medical device expiration date: 21-oct-2024; device manufacture date: 14-oct-2021.Medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.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 1 bd maxzero¿ multi-fuse extension set with needleless connector each from lots 21125635, 21115715, 21055457, and 21105940, as well as four separate, unspecified lots, had issues with leakage during use.The following information was provided by the initial reporter: "as just discussed, because our critical care areas had continuous leaking with bd set and filter mz9267 and 10011865, that resulted in product being pulled from those areas".
Additional Manufacturer Narrative
H6: investigation summar: samples were retained by customer and a company rep was able to bring them for shipping.Since the affected samples were dropped off, there has been no update on the tracking and they have not been received at our investigation facility.The complaint has been verified because samples were collected and a rep was able to retrieve them but without a formal investigation, the root cause remains unknown.Device history record review for model mz9267 lot numbers 21125635 (produced 09dec2021) , 21115715 (produced 16nov2021), 21055457 (produced 13may2021), 21105940 (produced 21oct2021) was performed.The search showed that a total of 7,203 units in lot numbers 21125635, 21115715, 21105940 and 4803 units in lot 21055457.There were no quality notifications issued for the failure mode reported by the customer during the build of these set.H3 other text : see h10.

• 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 ; 8015296192
• MDR Report Key: 14349779
• Report Number: 9616066-2022-00573
• Device Sequence Number: 17140844
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: 10885403240720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/25/2022

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: Other
• Device Expiration Date: 10/21/2024
• Device Catalogue Number: MZ9267
• Device Lot Number: 21105940
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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