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

Catalog Number	MZ9277
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd maxzero¿ extension set was loose, leaked and was blocked.The following information was provided by the initial reporter : the user reported that the new maxzero extension tubing is causing many issues.They are having problems drawing blood out of this tubing with the iv start, it is very stiff and tight just pushing saline through this tubing and because they are so difficult to push anything through the tubing is popping off at the iv hub, which leaves an open iv and blood is then dripping out.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ extension set was loose, leaked and was blocked.The following information was provided by the initial reporter : the user reported that the new maxzero extension tubing is causing many issues.They are having problems drawing blood out of this tubing with the iv start, it is very stiff and tight just pushing saline through this tubing and because they are so difficult to push anything through the tubing is popping off at the iv hub, which leaves an open iv and blood is then dripping out.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of loose component-leak-flow issue - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9277 lot number 21116093 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 09nov2021.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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14015339
• Report Number: 9616066-2022-00358
• Device Sequence Number: 12337593
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: 10885403240799
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/06/2022

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: 11/19/2024
• Device Catalogue Number: MZ9277
• Device Lot Number: 21116093
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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