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

Catalog Number MP5303-C

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported that 3 bd maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.D10: device available for eval yes.D10: returned to manufacturer on: 20-jan-2023.H6: investigation summary: three used samples and 38 unused samples (model #mp5303-c) were returned by the customer.It was reported by customer that "extension sets would not flush or draw".The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a 10ml bd syringe and attempted to be flushed with water.The sets were able to be flushed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model mp5303-c lot number 22109064 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that 3 bd maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET
• Type of Device: 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: 16080943
• MDR Text Key: 308465788
• Report Number: 9616066-2022-02102
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP5303-C
• Device Lot Number: 22109064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1