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.

Manufacturer Narrative

On 3/6/2024 two (2) used list #121949290 s primary plum 2 cl mp pe lind bc 2 were received for evaluation.Sample 1 was observed to be missing the piercing pin.When comparing the tubing to the other set the tube was observed to be slightly shorter.The deformation area in the tube had clean edges, typical of a cut with a sharp object.The two-clave tree above the sight chamber was also observed to be separated from the piercing pin.The deformation on the area of the break showed beach marks with smooth sections.Sample 2 was observed to have a partial separation at the clave tree connection above to sight chamber.The deformation on the area shows separation of the outer tubing had partial tearing in the inner tube.The complaint of tubing being holed can be confirmed.The probable cause is due to unintentional bending forces during use.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.Additional information - d9, h4 and h6 sections.

• 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,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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