MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9128
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified amount of bd maxguard¿ administration sets with needleless y-site had discolored drip chambers.The following information was provided by the initial reporter: "last night i noticed that several of the drip chambers on the primary tubing sets were discolored.They all seem to have come from the same 2 lots.I am not sure if the manufacturer sent any notices regarding this change in product or if there is something wrong with the integrity of the primary tubing from these lots.In the meantime, i pulled them from the nurse servers and they are currently at the nurses station.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary one photo was provided by the customer for investigation.The customer complaint of cosmetic issue - discolored was verified by evaluation of the photo submitted.The photo provided by the customer shows that the drip chamber has darkened in color.A device history record review for model mx9128 lot number 22039016 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to know physical sample being provided, the root cause for the discoloration of the drip chamber could not be determined.Based on the investigation of the photo submitted and previous similarities to complaints showing the same issue of the drip camber being discolored, the probable root cause of the issue is that the sterilization process can cause the drip chamber and tubing to become discolored over time.This does not affect the function or sterilization of the product.
Event or Problem Description
It was reported that an unspecified amount of bd maxguard¿ administration sets with needleless y-site had discolored drip chambers.The following information was provided by the initial reporter: "last night i noticed that several of the drip chambers on the primary tubing sets were discolored.They all seem to have come from the same 2 lots.I am not sure if the manufacturer sent any notices regarding this change in product or if there is something wrong with the integrity of the primary tubing from these lots.In the meantime, i pulled them from the nurse servers and they are currently at the nurses station.".

• Brand Name: BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17400401
• Report Number: 9616066-2023-01534
• Device Sequence Number: 7572340
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: 10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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 Catalogue Number: MX9128
• Device Lot Number: 22039016
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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