MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") AMBER TRANSFER SET W/CHEMOCLAVE® ADDITIVE PORT, ROTATING LUER, FILTE; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number 011-CH3657-10

Device Problem Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the event has been received by the manufacturer for further evaluation.No lot number was provided by the reporter; therefore the manufacturing and expiration dates are unknown.As additional information becomes available, a supplemental report will be submitted.

Event Description

It was reported that the device involved in the event was poorly connected to the tubing resulting in vincristine spilling on the patient.The reporter stated, the pullover of the patient absorbed most of the spillage but there were some drops on the patient's skin.Diphoterine was given to the patient to relieve a reported burning sensation and redness.No further harm to the patient was reported.No additional information if known at this time.

Manufacturer Narrative

The returned device was investigated and found to have insufficient solvent applied where the clave is bonded to the tubing resulting in a separation.The tubing was measured and found to be within specifications.No lot number was provided; therefore, no device history review was performed.The reported event was confirmed.

• Brand Name: 43 CM (17") AMBER TRANSFER SET W/CHEMOCLAVE® ADDITIVE PORT, ROTATING LUER, FILTE
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8667649
• MDR Text Key: 146958112
• Report Number: 9617594-2019-00156
• Device Sequence Number: 1
• Product Code: FMG
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CH3657-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY AGENT VINCRISTIN; DIPHOTERINE; CHEMOTHERAPY AGENT VINCRISTIN; DIPHOTERINE
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR