MAUDE Adverse Event Report: NDEHP PLUMSET 2CLAVES-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problem Particulates (1451)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The actual device is not available for evaluation, however, a photo sample is available.Investigation is not yet complete.

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch which was reported to have debris observed in the iv tubing.The customer reported that the product was sealed and the particulate was first noticed in tubing, and that the product was stored in the facility in bins in a climate controlled environment.There was patient involvement but not harm was reported as a consequence of the event.

Event Description

Additional information was received from the customer stating "that the iv tubing was put into use/opened at approximately 1630 on (b)(6) 2021; infusion completed and iv tubing disconnected on (b)(6) 2021 at approximately 0900" and that "the particulate was noticed at infusion discontinuation on (b)(6) 2021 at approximately 0900.".

Manufacturer Narrative

No product samples or videos were received for evaluation.An image was returned showing an anomaly in the tubing, it is not clear from the image what the nature of the object is.The customer reported that they had sent the object to a third party lab for identification, however no report of a result has been received.The complaint can be confirmed, the probable cause of the object cannot be determined from the information provided.A lot history review was performed and no nonconformities were found which would have contributed to the reported complaint.Additional information - b5 sectioncorrected information - section b4.

• Brand Name: NDEHP PLUMSET 2CLAVES-SL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12256465
• MDR Text Key: 264503279
• Report Number: 9615050-2021-00104
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)240301(10)5192798
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

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 Expiration Date: 03/01/2024
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: 5192798
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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