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

Catalog Number	MP5314-C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector tubing was blocked during use.The following information was provided by the initial reporter: "the tubing is blocked somehow-brand new but cannot get anything to go through.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 22069320.D4: medical device expiration date: 01jul2027.H4: device manufacture date: 17jun2022.H6: investigation summary 2 samples (model#mp5314-c) were returned for quality investigation by the customer.It was reported by customer that "tubing is blocked somehow-brand new but cannot get anything to go through".Prior to functional testing the sets were visually examined for defects and abnormalities.No other defects or abnormalities were observed.The sets were then attempted to be flushed with water using a 10 ml bd syringe and noticed that fluid was able to be flushed with even a slight push.Issue was not replicated.A device history record review for model mp5314-c and lot number 22079004 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04jul2022.A device history record review for model mp5314-c and lot number 22069320 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17jun2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The root cause of this complaint could not be definitively determined because the issue could not be replicated.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector tubing was blocked during use.The following information was provided by the initial reporter: "the tubing is blocked somehow-brand new but cannot get anything to go through.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16018925
• Report Number: 9616066-2022-02015
• Device Sequence Number: 5883702
• Product Code: FPA
• UDI-Device Identifier: 10885403236723
• UDI-Public: 10885403236723
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• 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): 01/18/2023

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 Catalogue Number: MP5314-C
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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