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

Model Number	MX4436
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22085615.Medical device expiration date: 18aug2025.Device manufacture date: 11aug2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxguard extension set with needleless y-site there were flow issues.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: as it was reported by customer that while using the bd primary gravity iv administration sets the product would not prime is because of the blue back check valve was put on backwards causing injected medication to flow up the iv bag rather than to the patient.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of misassembly - inverted component could not be verified due to the product not being returned for failure investigation.A device history record review for model mx4436 lot number 22085615 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.
Event or Problem Description
It was reported while using bd maxguard extension set with needleless y-site there were flow issues.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: as it was reported by customer that while using the bd primary gravity iv administration sets the product would not prime is because of the blue back check valve was put on backwards causing injected medication to flow up the iv bag rather than to the patient.

• Brand Name: BD MAXGUARD EXTENSION 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: 16140906
• Report Number: 9616066-2022-02188
• Device Sequence Number: 6610587
• Product Code: FPA
• UDI-Device Identifier: 50885403237476
• UDI-Public: (01)50885403237476
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/22/2023

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: Other
• Device Model Number: MX4436
• Device Catalogue Number: MX4436
• Device Lot Number: UNKNOWN
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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