MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS CLR POSITIVE DISPLACEMENT CONN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000C-0006

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one mp1000c-0006 sample was received without packaging for investigation; residual fluid was present within the component.No further information was available to assist the customer's experience in this instance.Pressure testing of the returned sample did not identify any leakage from the component; furthermore a visual inspection of returned sample did not identify any obvious cracks which may have contributed to the customer's experience.However analysis of the sample did identify some cloudiness at the joint of the maxplus housing and the male luer.A visual inspection revealed the presence of small white solvent like structures which could be seen at the joint between the male luer component and the blue component of the product.However no cracks were observed on the female luer.The mp1000c-0006 sample was connected to a bd plastipak 60ml syringe from stock, and the male luer was occluded to identify any leakage from the product.When placed underwater, no bubbling occurred, indicating that these white structures were not a source of leakage.Investigation conclusion: although this is not considered to be a product defect, the manufacturing site will continue to monitor reports of this nature during future production of this product.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the maxplus product.Root cause description: in this instance, it was not possible to confirm the customer's experience.Previous investigations have confirmed that the observed cloudiness can occur as a result of the ultrasonic welding process of the maxplus component, however please note this is deemed cosmetic defect in nature only and does not affect the functionality or integrity of the component.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.

Event Description

It was reported that cracks were seen in the maxplus clr positive displacement conn during use.The following information was provided by the initial reporter: "customer has reported another maxplus clear connectors showing cracks during use.".

• Brand Name: MAXPLUS CLR POSITIVE DISPLACEMENT CONN
• 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
• MDR Report Key: 12291763
• MDR Text Key: 265567007
• Report Number: 9616066-2021-51738
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP1000C-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 07/09/2021
• 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