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 MP5303-C

Device Problem Complete Blockage (1094)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported while using bd maxplus pressure rated extension set with removable needleless connector there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: extension set will not flush.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 25-apr-2023.H6: investigation summary: one sample (model #mp5303-c) was returned by the customer.It was reported by the customer that the extension set will not flush.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a 10 ml bd syringe and attempted to be flushed with water.The set was 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 could not be performed on model mp5303-c because a lot number is unknown.

Event Description

It was reported while using bd maxplus pressure rated extension set with removable needleless connector there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: extension set will not flush.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
• 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: 16757666
• MDR Text Key: 313483827
• Report Number: 9616066-2023-00708
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403236652
• UDI-Public: (01)20885403236652
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 06/29/2023
• 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