MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 UNITS OF EXT SET TUBING PUR YELLOW W/ SPIKE,Y-CLAVE®, CLAMP, LUER CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number 011-H2394

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event involved a 28 cm (11") appx 2.5 ml, set ambrato per infusione 2 clave® connector, perforatore con filtro, where it was reported upon starting chemotherapy it was noticed the tubing had a crack between the base between the bag of chemotherapy and the start of the priming system.There was a crack visible with flow of product resulting in increased exposure to chemotherapy, loss of part of the product and the dose of chemotherapy.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

Additional information located in sections d1, d4, d9 (device returned to mfr on 2/2/2023), and h3.

Manufacturer Narrative

The complaint of damaged tubing can be confirmed on the returned one used unit.List #011-h2394, 5 units of ext set tubing pur yellow with spike, y-clave®, clamp, luer check valve; lot #unknown.As received there was a tear in the tubing just below the piercing pin.The tear was jagged.No other damages or anomalies noted.The set was leak tested per product specification.There was a leak from the hole observed.There were no other leaks or damages observed.The probable cause of the tear observed in the tubing is unknown.

Event Description

The event involved a 5 units of ext set tubing pur yellow with spike, y-clave®, clamp, luer check valve, where it was reported upon starting chemotherapy it was noticed the tubing had a crack between the base between the bag of chemotherapy and the start of the priming system.There was a crack visible with flow of product resulting in increased exposure to chemotherapy, loss of part of the product and the dose of chemotherapy.There was patient involvement, however no report of patient harm.

• Brand Name: 5 UNITS OF EXT SET TUBING PUR YELLOW W/ SPIKE,Y-CLAVE®, CLAMP, LUER CHECK VALVE
• 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: 16273400
• MDR Text Key: 308503379
• Report Number: 9617594-2023-00049
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• 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,Followup
• Report Date: 01/10/2023

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 Catalogue Number: 011-H2394
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 03/23/2023; 04/27/2023
• Supplement Dates FDA Received: 04/20/2023; 05/17/2023
• 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: UNSPECIFIED CHEMOTHERAPY, UNK MFR