MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI; STOPCOCK, I.V. SET

Model Number B9259

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.

Event Description

The incident involved a 17" (43 cm) extension set with clave®, 0.2 micron filter, clamp, rotating luer on an unknown date.The reporter stated that the device keeps leaking during infusions.The patient was in the infusion chair receiving paclitaxel through the device when the device started leaking through the clave site.The infusion was immediately stopped, and a new dose was made using a new tubing set from the same lot and it also started to leak when the infusion was started.The nurse was exposed to paclitaxel on her hands.There were no holes, cuts, tears or any defect noted in the device.The set up was paclitaxel running through a plum 360 infusion pump.The 17¿ extension set with 0.2micron filter was attached to the end of the primary tubing set.It was further stated that there was patient involvement but no harm to the patient or to the healthcare provider and no delay in therapy that was critical to the patient.This is the first of two incidents.

Manufacturer Narrative

Seven new sets from the same lot as the affected sets were returned by the customer.Each of the new extension sets were pressure leak tested, and each met pressure leak expectations outlined in the product performance specification.The complaint of leakage was unable to be replicated or confirmed with the new extension sets returned for investigation.The actual affected samples were not returned for investigation and evaluation.A device history review for the reported lot number was performed, and the following discrepancies were identified.During physical functional testing on 30-apr-2022, quality assurance found that cavity d37 failed the crack test.Bodies were found with broken core pin in cavity b1, degraded material, shortshots and knitlines in bodies.On 17-apr-2022.Quality assurance found that cavity d34 failed the crack test.D9: product was returned to manufacturer on 09-jan-2023.

• Brand Name: 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16014446
• MDR Text Key: 308247286
• Report Number: 9617594-2022-00330
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B9259
• Device Catalogue Number: B9259
• Device Lot Number: 5847625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: PACLITAXEL, MFR UNK; PLUM360 PUMP, ICU MEDICAL; PRIMARY PLUM SET TUBING 103 INCH, ICU MEDICAL