MAUDE Adverse Event Report: 8 IN KINK RESISTANT SET W/MAXPLUS; INTRAVASCULAR ADMINISTRATION SET

Model Number MP9081-C

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the 8 in kink resistant set w/maxplus experienced ruptured tubing.The following information was provided by the initial reporter: sales rep has a customer that informed him that the maxplus extension set mp9081-c is bursting around 250 psi.Says packaging says burst rate is around 325 psi.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the maxplus extension set is bursting around 250 psi.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mp9081-c because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that the 8 in kink resistant set w/maxplus experienced ruptured tubing.The following information was provided by the initial reporter: sales rep has a customer that informed him that the maxplus extension set mp9081-c is bursting around 250 psi.Says packaging says burst rate is around 325 psi.

• Brand Name: 8 IN KINK RESISTANT SET W/MAXPLUS
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12136924
• MDR Text Key: 260531138
• Report Number: 9616066-2021-51480
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403236912
• UDI-Public: 50885403236912
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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 Model Number: MP9081-C
• Device Catalogue Number: MP9081-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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