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

Catalog Number MP1000 CHINA

Device Problem Complete Blockage (1094)

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

Event Date 12/30/2023

Event Type  malfunction  

Event Description

It was reported that bd maxplus needleless connector was occluded the following information was received by the initial reporter with the following verbatim: on (b)(6) 2023, the patient suffered from heart failure.He was given infusions as directed by the doctor and established an intravenous indwelling needle to connect to the needleless connector.It was found that the needleless connector was blocked and was replaced immediately.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Investigation results: no samples were received for investigation of pr (b)(4), in which the customer has stated: ¿the needleless connector was blocked¿.The product in use at the time is reported to be a mp1000 china from lot 22125382.Further information from the customer stated that the flow was blocked completely and also they confirms that there were no visible damages on the product.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 22125382 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.Previous investigations have identified that certain designs of male luer can cause flow restriction or occlusion as they can grip onto the piston of the maxplus preventing its proper collapse.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mp1000 china products in the past 12 months.

Event Description

No additional information.

• Brand Name: BD MAXPLUS 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18934655
• MDR Text Key: 338336331
• Report Number: 9616066-2024-00434
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403238321
• UDI-Public: (01)10885403238321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP1000 CHINA
• Device Lot Number: 22125382
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1