MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 50 CM (20") TRANSFER SET W/CLAVE SPIKE, 0.2 MICRON FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-H3532

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event occurred on an unspecified date and involved a 50 cm (20") transfer set w/clave¿ spike, 0.2 micron filter, rotating luer, and was reported as the air is not evacuated at the level of the filter and therefore rises in the tubing upstream of the filter.There was no patient involvement and no report of adverse event.

Manufacturer Narrative

Additional information in section b5 and d9.No product samples, videos, or photographs were returned for investigation.The device history review (dhr) for lot number 4736108 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information that has been provided.

Event Description

Additional information received that the incident occurred during the reconstitution of the cytotoxic in cru, before dispensation from the bag to the service.It was also reported that the device contained possible traces of nivolumab antibodies.

• Brand Name: 50 CM (20") TRANSFER SET W/CLAVE SPIKE, 0.2 MICRON FILTER, ROTATING LUER
• 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: 10527531
• MDR Text Key: 206790821
• Report Number: 9617594-2020-00381
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619067090
• UDI-Public: (01)00840619067090(17)250201(10)4736108
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• 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: 08/28/2020

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-H3532
• Device Lot Number: 4736108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1