MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE CONNECTOR IV BAG ACCESS DEVICE; STOPCOCK, I.V. SET

Catalog Number	011-CS-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples were returned for investigation, however, two photographs were returned showing a (b)(4) bag spike inserted into a drug bag.There was a towel under the spike/bag assembly and wetness was confirmed under a large portion of the area under the (b)(4) bag spike inserted into a drug bag.It was not possible to determine from the photo the origination of the leakage.The device history review was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The probable cause of the leakage cannot be determined from the photo and information provided.
Event or Problem Description
The event involved a clave¿ connector iv bag access device that leaked cyclophosphamide.It was reported that during infusion, a solution container of cyclophosphamide was found to be leaking from the clave attachment when it was hung.There was no leak observed when unpacking the container and there was no observable damage to the clave attachment.The patient was sitting, waiting for treatment.There was patient involvement, no skin contact with the cytotoxic solution by the patient or nursing staff, no report of patient harm or injury or medical intervention as a result of this event, however one of the nurses reported having a headache after the product leaked.The headache was temporary and resolved after the container was discarded.

• Brand Name: CLAVE CONNECTOR IV BAG ACCESS DEVICE
• Common Device Name: 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: 10679171
• Report Number: 9617594-2020-00444
• Device Sequence Number: 3110366
• Product Code: FMG
• UDI-Device Identifier: 00840619005955
• UDI-Public: (01)00840619005955(17)250401(10)4773465
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Catalogue Number: 011-CS-10
• Device Lot Number: 4773465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1