MAUDE Adverse Event Report: ICU MEDICAL INC. ONCOLOGY KIT 12 INCH TUBING; FLUID TRANSFER SET, GENERAL-PURPOSE

Catalog Number CH3943

Device Problems Nonstandard Device (1420); Improper Flow or Infusion (2954)

Patient Problem Discomfort (2330)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

'patient came in, urinalysis was tested, consulted with nurse practitioner (np) to proceed with bacille calmette-guérin (bcg) chemotherapy due to no infection, patient was prepped, vitals were taken, np came into procedure room, lidocaine injection performed into the tip of the penis, catheter was inserted by np, bcg line was attached to catheter, there was no pressure flow from bcg bottle into catheter, squeezed bottle several times and inverted, no bubbles noted, advanced catheter inverted bcg bottle, no bubbles noted, stopped procedure due to patient discomfort and faulty bcg lines, removed catheter and bcg still did not flow without resistance, patient was rescheduled, no injuries noted to patient' approximately 1/3 to 1/2 of medicine was instilled, but patient had a bladder spasm and an undetermined amount of fluid was expelled from bladder.After few days staff noted the bcg tubing had been recalled.New supply of bcg tubing ordered and received.Rescheduled treatment was performed after that.Manufacturer response for bcg tubing, oncology kit (per site reporter).Icu medical customer service notified of equipment failure by online form.Response received from senior customer care representative, supply chain solutions.

• Brand Name: ONCOLOGY KIT 12 INCH TUBING
• Type of Device: FLUID TRANSFER SET, GENERAL-PURPOSE
• Manufacturer (Section D): ICU MEDICAL INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10934232
• MDR Text Key: 219153386
• Report Number: 10934232
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3943
• Device Lot Number: 4724725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2020
• Event Location: Other
• Date Report to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA