MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a plum set where a hole was found on the tubing which resulted in a leak, 10 minutes after infusion of nicardipine, for high blood pressure treatment.There was no unprotected exposure to the drug leak.There was patient involvement but no patient harm.No additional information was provided.

Manufacturer Narrative

Received an image from the customer showing the set, with fluid, inside of a bag.No damage or anomalies were evident from the image.Received one used, list #146870489 (primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #5192799) and one used needle (list #unknown, lot #unknown).The set was visually examined and a large cut was found in the tubing.The set was air pressure leak tested and the aforementioned cut was the only leak site.The cut was examined and the edges were clean.No packaging was returned for evaluation.The complaint can be confirmed, the probable cause is due to contact with a sharp instrument during use.The manufacturing process was reviewed and it was determined that this type of damage would not have occurred during manufacturing.There are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: NDEHP PLUMSET 2CLAVES-SL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12550314
• MDR Text Key: 274075660
• Report Number: 9615050-2021-00138
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)240301(10)5192799
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 5192799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NICARDIPINE, MFR UNK