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 Leak/Splash (1354)

Patient Problem Anxiety (2328)

Event Date 02/24/2023

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.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd maxplus¿ pressure rated extension set leaked.The following information was provided by the initial reporter: they have had have leakage issues with the extension set mp5303-c.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 20-mar-2023.H6: investigation summary: one used sample of material number mp5303-c was returned for quality investigation by the customer.It was reported by the customer that the extension set is having leakage issue was not observed in returned sample.Prior to functional testing the samples were visually examined for defects and abnormalities.No defects or abnormalities were observed.The samples were then attempted to be flushed with blue dart solution using a 10ml bd syringe to confirm the leakage.The failure of leakage 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 and lot number 22119093 was performed.There was no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.

Event Description

It was reported that the bd maxplus¿ pressure rated extension set leaked.The following information was provided by the initial reporter: they have had have leakage issues with the extension set mp5303-c.

• 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 ; 8448235433
• MDR Report Key: 16569576
• MDR Text Key: 311702042
• Report Number: 9616066-2023-00485
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236655
• UDI-Public: 10885403236655
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1