MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRI PLUM 2 CL MP PE LIND BC 213CM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 121949290

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

The event involved als pri plum 2 cl mp pe lind bc 213cm where the customer stated that the device had a hole in it and leaked during patient use of nacl 0.9%.The nurse was sprayed but no consequences because the product is a non-toxic one.There was a certain delay in therapy but is unknown for how long and the full intended dose was administered.The leak has been cleaned up according to facility protocol.It was unknown what was the patient's condition before, during and after the incident.There was patient involvement, but harm was not reported as a consequence of this event.

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.

• Brand Name: LS PRI PLUM 2 CL MP PE LIND BC 213CM
• 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: 18949593
• MDR Text Key: 338448452
• Report Number: 9615050-2024-00243
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: (01)(17)260801(10)13670709
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121949290
• Device Lot Number: 13670709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Treatment: NACL 0.9% MFR UNK