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

Catalog Number MP1000 CHINA

Device Problems Complete Blockage (1094); Excess Flow or Over-Infusion (1311)

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

Event Date 09/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd maxplus needleless connector had flow issues.The following information was received by the initial reporter with the verbatim; the patient visited our hospital mainly due to acute myocardial infarction and emphysema.He used infusion according to the doctor's instructions on september 23, 2023.After the needleless connector was connected to the infusion set, the fluid line did not stop, so the needleless connector was replaced.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: no samples were received for investigation of pr 9312856, in which the customer has stated: ¿after the needleless connector was connected to the infusion set, the fluid line did not stop¿.The product in use at the time is reported to be a mp1000 china from lot 22125382.No further information was available to assist the investigation in this instance.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.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 an isolated occurrence with no further reports of this nature against the mp1000 china products in the past 12 months.

• 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: 18341437
• MDR Text Key: 330705351
• Report Number: 9616066-2023-02410
• 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,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 12/22/2023
• 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