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 14687-15

Device Problem Break (1069)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch where damaged tubing was reported.The event occurred during infusion.There was patient involvement but no patient harm.

Manufacturer Narrative

Received a photo from the customer showing tubing split in two.Received one used list #14687-15 primary plum set.As received, the tubing after the cassette and before the y-clave was observed to be cut.The complaint of tubing damage on the 14687-15 primary plum set can be confirmed.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The complaint of tubing damage can be confirmed.The cause of the damage is unknown; however, it would have occurred outside of icu medical control.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 18580220
• MDR Text Key: 333822777
• Report Number: 9615050-2024-00072
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260501(10)13615680
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14687-15
• Device Lot Number: 13615680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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