MAUDE Adverse Event Report: PLEXITRON SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MRC0001MP

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the slide clamp of a plexitron solution administration set was damaged; further described as free flow with the slide clamp closed.This occurred during priming.It was further stated that the patient¿s bed was wet and that the patient was getting wet as well.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction to f10/h6: medical device problem codes - replace a0204 with a0401.H10: the actual device was not available; however, a video of the sample was provided for evaluation.A visual inspection was performed on the video sample which observed free flow of solution through the drip chamber.Due to the nature of the sample, no additional tests could be performed.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PLEXITRON SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12262808
• MDR Text Key: 264718832
• Report Number: 1416980-2021-04692
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141305553
• UDI-Public: (01)07707141305553
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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: Health Professional
• Device Catalogue Number: MRC0001MP
• Device Lot Number: SE21CC6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2020
• 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
• Patient Age: 20 YR