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

Model Number	MX9059
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were multiple occurrences of the bd extension set maxplus¿ experiencing foreign matter.The following information was provided by the initial reporter: it was found that there is yellowing component.
Additional Manufacturer Narrative
Investigation summary: twenty samples were submitted for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Evaluation of the samples submitted identified a yellow discoloration in the tubing and extension set connectors.No other issues were found during the investigation.A device history record review for model mx9059, lot number 21065711 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28jun2021.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 mx9059, lot number 21045469 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06apr2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A review of the sterilization record for item #mx9059, lot 21065711 shows that the extension sets were sterilized in (b)(6) 2021.A review of the sterilization record for item #mx9059, lot 21045469 shows that the extension sets were sterilized in (b)(6) 2021.The root cause for the issue seen in this complaint is a result in the sterilization process.Previous complaints have seen a similar issue with discoloration of extension set tubing, with the tinting of the tubing increasing over time.Previous investigations have shown that the discoloration does not affect the performance or sterility of the product.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21045469, medical device expiration date: 06-apr-2026, device manufacture date: 05-apr-2021; medical device lot #: 21065711, medical device expiration date: 28-jun-2026, device manufacture date: 09-jun-2021.

• Brand Name: BD EXTENSION SET MAXPLUS¿
• 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: 14754884
• Report Number: 9616066-2022-00743
• Device Sequence Number: 1334348
• Product Code: FPA
• UDI-Device Identifier: 50885403237582
• UDI-Public: 50885403237582
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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 Model Number: MX9059
• Device Catalogue Number: MX9059
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/21/2022
• 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