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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
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 the bd maxguard¿ administration set with needleless y-site leaked blood onto the patient's bedding during use.The following information was provided by the initial reporter: "they are stating that there were changes made to the product's hub that affect the patients when the product used to connect seamlessly.The part where the tubing is hooked to the iv site is difficult to connect to the iv site.It is leaking and getting blood on the bedding.Trying to attach it to the patient causes them to apply pressure to the patient which causes the patient pain.".
Event or Problem Description
It was reported that the bd maxguard¿ administration set with needleless y-site leaked blood onto the patient's bedding during use.The following information was provided by the initial reporter: "they are stating that there were changes made to the product's hub that affect the patients when the product used to connect seamlessly.The part where the tubing is hooked to the iv site is difficult to connect to the iv site.It is leaking and getting blood on the bedding.Trying to attach it to the patient causes them to apply pressure to the patient which causes the patient pain.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model mx9128 lot number 22099046 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 no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15921230
• Report Number: 9616066-2022-01864
• Device Sequence Number: 19455881
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: (01)10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/20/2022

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: 09/07/2025
• Device Catalogue Number: MX9128
• Device Lot Number: 22099046
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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