MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 146870489

Device Problem Material Separation (1562)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If the device becomes available a supplemental report will be submitted.E1 initial reporter phone number: (b)(6).

Event Description

The event occurred on an unspecified date and involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inc where it was reported that the tubing breaks easily.The customer reported to see if the adhesive coming apart was easily replicable.They were not able to easily replicate with the same product.The customer was easily able to replicate with minimal force with this lot number that they had in stock at the time of the event.During their attempt to replicate, they noticed that the adhesive responds differently in different products.They were able to replicate with most sets available on site but not of the lot that the event occurred with.The product has been used before it was noticed.No patient harm was reported.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18111611
• MDR Text Key: 328658198
• Report Number: 9615050-2023-00622
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260101(10)13493354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 146870489
• Device Lot Number: 13493354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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