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

Catalog Number MPX5300-C

Device Problem Complete Blockage (1094)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/14/2022

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 3 of the bd maxplus¿ extension set is not allowing us to draw blood or flush an iv from either port.The following information was provided by the initial reporter: this extension set is not allowing us to draw blood or flush an iv from either port.This has happened on 3 separate occasions, so it is not consistent but is an issue.

Event Description

It was reported that 3 of the bd maxplus¿ extension set is not allowing us to draw blood or flush an iv from either port.The following information was provided by the initial reporter: this extension set is not allowing us to draw blood or flush an iv from either port.This has happened on 3 separate occasions, so it is not consistent but is an issue.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint that the extension set was unable to flush could not be verified due to the product not being returned for failure investigation.A device history record review for model mpx5300-c lot number 22079199 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.

• Brand Name: BD MAXPLUS¿ 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: 16091355
• MDR Text Key: 308586053
• Report Number: 9616066-2022-02112
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (y/n): Y
• 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: 01/12/2023

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
• Device Operator: Other
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 22079199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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