MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN; STOPCOCK, I.V. SET

Catalog Number 011-CH3657

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device is reported to be available for evaluation but has not yet been received.

Event Description

The event involved a 43 cm (17") appx 2.8 ml, amber transfer set w/chemoclave® additive port, rotating luer, filter cap while infusing chemotherapy drug, doxorubicine at the chemotherapy unit.The device was reported to have leaked at the level of the connection to the extension set.It was reported that the patient did not received the entire treatment.The device was replaced with no further problems encountered.There was exposure to the chemotherapy drug, however, no adverse events, no delay in therapy, and no need for medical intervention.

Manufacturer Narrative

H10: evaluation results.No product samples, videos, or photographs were returned for investigation.The dhr for lot number 4734811 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Should the actual device be received for evaluation, a supplemental report will be submitted.Additional information can be found in section d10.

• Brand Name: 43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN
• 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
• MDR Report Key: 10937192
• MDR Text Key: 219573477
• Report Number: 9617594-2020-00523
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619095550
• UDI-Public: (01)00840619095550(17)250301(10)4734811
• Combination Product (y/n): N
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CH3657
• Device Lot Number: 4734811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOXORUBICINE (UNK MFR).