MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO; STOPCOCK, I.V. SET

Catalog Number 011-H1268

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a 4-way ¿tree¿ device 30 cm (12") appx 3.1 ml, set per infusione, 4 clave® connector, filtro.The customer stated that the 4-way chemo tree has a connection fault on the blue tips which become misfit at the slightest manipulation.This occurred while removing chemotherapy premedication for a patient.The nurse pulled on the nozzle and it separated from the rest, causing a leak of chemotherapy premedication on the patient¿s pants.The customer states that the device was exchanged out with another chemotherapy tree.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

The complaint of separation and leakage can be confirmed on the 30 cm (12") appx 3.2 ml, set per infusione, 4 clave® connector, filtro; lot #5600120.As received one of the adapters was separated on the returned set.The adapter and boding pocket were examined.There was insufficient solvent coverage observed.The probable cause of the separation is due to insufficient solvent coverage applied during manual assembly at the manufacturing site.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg- 10/18/2022.

• Brand Name: 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO
• 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: 15546324
• MDR Text Key: 306681523
• Report Number: 9617594-2022-00286
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619008291
• UDI-Public: (01)00840619008291(17)260901(10)5600120
• 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
• Report Date: 09/08/2022

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-H1268
• Device Lot Number: 5600120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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 PREMEDICATION, UNK MFR