MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP5313-C
Medical Device Problem Codes	Backflow (1064); Complete Blockage (1094); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector check valve malfunction failed, causing flow issues and blood backflow during use.The following information was provided by the initial reporter: "this issue is with the pigtail iv set.The rubber inside the valve is not closing in the opening after use.The vacutainer is inserted, i withdraw blood but when i am done and try to disconnect the rubber inside is not recoiling and closing the valve, leaving blood to backflow.".
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the valve is not closing leaving the blood to backflow.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5313-c lot number 20126036 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.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #20126036 regarding item #mp5313-c.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector check valve malfunction failed, causing flow issues and blood backflow during use.The following information was provided by the initial reporter: "this issue is with the pigtail iv set.The rubber inside the valve is not closing in the opening after use.The vacutainer is inserted, i withdraw blood but when i am done and try to disconnect the rubber inside is not recoiling and closing the valve, leaving blood to backflow.".

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12778018
• Report Number: 9616066-2021-52388
• Device Sequence Number: 6025808
• Product Code: FPA
• UDI-Device Identifier: 50885403236714
• UDI-Public: 50885403236714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/18/2021

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: 12/10/2023
• Device Model Number: MP5313-C
• Device Catalogue Number: MP5313-C
• Device Lot Number: 20126036
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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 Age: 73 YR
• Patient Sex: Unknown
• Patient Race: White