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

Catalog Number MP1000 CHINA

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Catalog # mp1000 china/no 510k this is an international code- the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mp1000.The 510k number provided for the domestic similar product.-k072542 a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 9 maxplus positive pressure connectors experienced spontaneous disconnection.The following information was provided by the initial reporter: mp1000- needle - free connector - rubber plug has rebound big.Photo cannot be provided.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6) 2020.H6: investigation summary five mp1000 china samples were received for investigation in opened packaging; two from lot 20055179 and three from lot 20055178.No obvious residual fluid was present within the samples and the protective caps were in place.Further information provided by the customer indicates that the connection issues were observed with a luer slip syringe, however this was not provided for investigation.A visual inspection did not identify any obvious signs of damage or manufacturing defects which could have contributed to the customer's experience.The samples were subjected to functional testing by connecting each to a 10ml bd luer slip syringe from retained stock and flushing with fluid; no bounceback, leakage or connection issues were identified during testing.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.A review of the production records for lot 20055179 and 20055178 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance the user facility has opted to use a luer slip syringe therefore the connection to the maxplus valve is a friction fit and relies on the user ensuring that the syringe is securely fitted before use.As stipulated in the user instructions a luer slip syringe should not be left unattended.The directions for use states that ¿if syringe has a luer slip, insert and rotate ¼ turn clockwise to secure connection.Do not leave luer slip unattended¿.A review of the customer feedback database indicates that reports of this nature against the maxplus device occur at a low frequency and have not been attributable to a product defect or manufacturing issue.

Event Description

It was reported that 9 maxplus positive pressure connectors experienced spontaneous disconnection.The following information was provided by the initial reporter: mp1000- needle - free connector - rubber plug has rebound big.Photo cannot be provided.

• Brand Name: MAXPLUS POSITIVE PRESSURE 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 22244 ; MX 22244
• MDR Report Key: 11089975
• MDR Text Key: 225149011
• Report Number: 9616066-2020-20671
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 20055178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1