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

Model Number 1468728

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

The event involved a plumset that he customer reported a hair was observed in the cassette.There is no report of adverse event.No additional information was provided.

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Manufacturer Narrative

Received one list #146870489, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #unknown, one used.List #unknown, spiros connector with tubing; lot #unknown on november 30, 2021 for evaluation.The customer returned an image appearing to show a hair in the cassette.As received, the set was visually inspected and the hair was confirmed to be inside of the cassette, in the fluid path.No other anomalies were found.The complaint can be confirmed.The probable cause is due to an error during the gowning process.A lot review could not be conducted because no lot number(s) was/were identified.

• 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: 12847179
• MDR Text Key: 284899782
• Report Number: 9615050-2021-00164
• Device Sequence Number: 1
• Product Code: FPA
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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