MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.29 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, NANOCLAVE¿, CLAM; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 41237-06

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

The event involved a td torque-line catheter, 8f, 5 lumen, 110 cm, ra/ra, heparin coated, lf where it was reported the swan ganz catheter (pentalumen) spontaneously broke while in patient with pressurized bag attached.The catheter was removed from the patient.There was blood backflow, but no significant blood loss.The product came into contact with 0.9% normal saline that was used for priming and as a part of the pressure monitoring set-up.It came into contact with blood when the lumen broke and allowed blood to backflow from the patient.The nurse stated that the swan ganz catheter was used for hemodynamic monitoring and clinical decision making did have to be removed.At the time of her inquiry, the nurse manager did not state that the catheter had been replaced.There was no reported harm.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

The reported sample of one (1) used list #412370406, td torque line catheter was received for evaluation.During visual inspection, the proximal tubing was broken from the female luer.A part of the proximal tubing was inside the luer pocket of the female luer.Tool marks were observed on the tubing.A pull test was conducted on a representative bond: distal tubing and the female luer, the tubing broke near the luer at 15 lbs within the specifications limit of 6 lbs.The reported complaint of separation was confirmed.The probable cause for the breakage of the tubing had occurred due to unintentional external forces applied during use.A device history record could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7" (18 CM) APPX 0.29 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, NANOCLAVE¿, CLAM
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: 16359110
• MDR Text Key: 309519527
• Report Number: 9617594-2023-00075
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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 Model Number: 41237-06
• Device Catalogue Number: 412370406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/04/2023
• 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
• Treatment: 0.9% NORMAL SALINE, MFR UNK; PRESSURIZED BAG , MFR UNK