MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 01C-C2202

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a smallbore bifuse ext set w/2 microclave®, rotating luer, where leakage was noted between the connector and extension set when infusing 5-fu after 2 hours, via an unspecified pump.The chemo spill was not cleaned up per facility protocol and a spill kit was not used.Although it was reported that there was unprotected chemo exposure, and the chemo came in contact with the patient, and healthcare provider, there was no patient harm, and no adverse effects to patient, and healthcare professionals reported.

Manufacturer Narrative

H10 - no product samples, videos, or photographs were returned for investigation.A device history review could not be conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE, 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: 10680306
• MDR Text Key: 211364191
• Report Number: 9617594-2020-00445
• Device Sequence Number: 1
• Product Code: FMG
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01C-C2202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5-FU, MFR UNK; UNSP TUBING SET, MFR UNK; UNSPEC PUMP, MFR UNK; 5-FU, MFR UNK; UNSP TUBING SET, MFR UNK; UNSPEC PUMP, MFR UNK