MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-H3394

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The complaint/event occurred on an unspecified date and involved a 30 cm (12") add-on set w/4 check valves, vented cap.It was reported that a tubing/line became detached during an administration of chemotherapy.There were no clinical consequences for the patient, nor for the healthcare staff.There was no adverse event or human harm associated with the complaint/event.

Manufacturer Narrative

The following items were provided by the customer for complaint investigation: -one used list #011-h3394, 30 cm (12") add-on set w/4 check valves, vented cap; lot #12734044.--one used list #unknown, extension set w/ drip chamber; lot #unknown.One used list #unknown, extension set w/ orange tubing; lot #unknown.Two used list #unknown, 0.9% sodium chloride 250ml bag; lot #13sff121.Photos were also provided showing the unit packaging label as well as the 011-h3394 assembly with a circle around a bond separation between the tubing and the proximal end of the trifurcated adapter.The returned used 011-h3394 assembly had a confirmed bond separation between the tubing and the proximal end of the trifurcated adapter.Examination of the bond using uv light revealed that the bond had insufficient solvent coverage with led to the bond separation.The probable cause of the bond separation is typical of insufficient solvent coverage during manual bond assembly in the manufacturing process.Date returned to mfg: 09feb2024corrected information can be found in b3 and h6, medical device problem code.

Event Description

Additional information was received from the customer on january 02,2024 as follows: the event occurred on (b)(6) 2023.There was no physical defect with the device identified before use.There was no unprotected exposure to any cytotoxic product for the patient nor for the healthcare provider.There was a delay in therapy of 1 step of the procedure, the tubing has not been changed, the therapy has been stopped and there was no blood loss.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18412747
• MDR Text Key: 331544982
• Report Number: 9617594-2023-01205
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619058050
• UDI-Public: (01)00840619058050(17)271101(10)12734044
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070532
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3394
• Device Lot Number: 12734044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: CYCLOPHOSPHAMIDE, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK