MAUDE Adverse Event Report: 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 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that 5 maxplus clr positive displacement conn leaked.The following information was provided by the initial reporter: "this is the third reported occurrence of a cracked connector.These were not kept for my perusal.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-01.H6: investigation summary.Two mp1000c-0006 products were received without packaging for investigation.The customer feedback indicate the affected product was from lot 20056572, 20065649 or 20065650.No connecting products were received to assist the investigation.Further information provided by the customer indicates that the damage was observed early on into use, and the maxplus components were connected to bd extension sets; additionally the customer confirmed that the maxplus are typically disinfected with 3m soluprep antiseptic wipes 92%w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol.A visual inspection of the received samples confirmed the customer's experience as a crack was identified on the female luer adaptor of the maxplus components; in each instance leakage was observed from the crack.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 20056572, 20065649 and 20065650 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The type of crack observed can be caused or contributed to by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.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.

Event Description

It was reported that 5 maxplus clr positive displacement conn leaked.The following information was provided by the initial reporter: "this is the third reported occurrence of a cracked connector.These were not kept for my perusal.".

• Brand Name: MAXPLUS CLR POSITIVE DISPLACEMENT CONN
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12502283
• MDR Text Key: 272476367
• Report Number: 9616066-2021-52081
• 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,Followup
• Report Date: 09/28/2021

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: MP1000C-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/21/2021
• 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