MAUDE Adverse Event Report: MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000-C CHINA

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the maxplus positive pressure connector the device was clogged/blocked/occluded.This event occurred 6 times.The following information was provided by the initial reporter and translated to english.The customer stated: "needle-free joint -- the joint does not run liquid, the product is retained, and green claims are required.6 defective products.".

Event Description

It was reported when using the maxplus positive pressure connector the device was clogged/blocked/occluded.This event occurred 6 times.The following information was provided by the initial reporter and translated to engloish.The customer stated: "needle-free joint -- the joint does not run liquid, the product is retained, and green claims are required.6 defective products.".

Manufacturer Narrative

H6: investigation summary one mp1000c-china sample was received for investigation from lot 20015137.The sample was received connected to the male luer of a gravity set of unknown manufacturer.No packaging was received for either product, and the gravity set had residual fluid present in the line.Attempts to flush the contents of the gravity set were mostly unsuccessful, as there appeared to be a flow restriction in the drip chamber filter; therefore, in order to perform luer compatibility testing, the male luer was cut away from the rest of the set.Flow restriction was observed when fluid was administered via the male luer of the gravity set; however no flow restriction was observed through the maxplus when tested with a 50ml bd plastipak syringe.A visual inspection of the male luer of the returned infusion set noted a distinct raised ring around the outer edge of the male luer tip, which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20015137 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Previous investigations have identified that this design of male luer can cause flow restriction or occlusion as it 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.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxplus product in the past 12 months.H3 other text : see h10.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12519931
• MDR Text Key: 272936787
• Report Number: 9616066-2021-52114
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP1000-C CHINA
• Device Lot Number: 20015137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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