MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1427329

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

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for return.The device has not been received.

Event Description

The event involved a plum burette set where it was reported that a hair was observed in the cassette.There is no report of patient harm, however there was patient involvement as this was noted during patient infusion.

Manufacturer Narrative

Received one used list #142730490, plum 150 ml burette set, clave injection site, (b)(6), 114in; lot #5455899.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 probable cause is due to an error during the gowning process during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PLUM BURETTE CLAVE SITES 114IN NDEHP
• 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: 13290229
• MDR Text Key: 284897582
• Report Number: 9615050-2022-00008
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)240701(10)5455899
• 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: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1427329
• Device Catalogue Number: 142730490
• Device Lot Number: 5455899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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