MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H10; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5305
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd maxzero multi-fuse pressure rated extension set with needleless connector(s) experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: prior to use the customer observed brownish discoloration to the tubing.The tubing is still transparent but has a brownish tint.
Additional Manufacturer Narrative
Medical device brand name: bd maxzero multi-fuse pressure rated extension set with needleless connector(s).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20075813, medical device expiration date: 23-jul-2023, device manufacture date: 06-jul-2020.Medical device lot #: 20106826, medical device expiration date: 23-oct-2023, device manufacture date: 23-oct-2020.Investigation summary: five samples were submitted for quality investigation.The customer complaint of cosmetic issues -discolored was verified by visual inspection.Evaluation of the samples submitted indicates that the tubing of the extension set assembly looks to have a dark yellow like tint.The samples are in unopened packaging and unused.A device history record review for model mz5305 lot number 20075813 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mz5305 lot number 20106826 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the discoloration of the tubing is the sterilization of the assembly.The sterilization process can cause a tinting to appear in the tubing of the assembly.This darkening of the tube increases over time and the tubing can appear dark yellow or dark brown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: SEE H10
• 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: 14431675
• Report Number: 9616066-2022-00620
• Device Sequence Number: 5604409
• Product Code: FPA
• UDI-Device Identifier: 10885403230585
• UDI-Public: 10885403230585
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/02/2022

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 Catalogue Number: MZ5305
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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