MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS; SYRINGE, PISTON

Catalog Number	CH-74-10
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	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples of the concerned lot are available for evaluation.They are yet to be received.
Event or Problem Description
The event occurred on an unknown date and involved a locking universal vented vial spike, clave, 10 units that leaked chemotherapy during preparation.The customer reported that several preparers had leakage issues.They found the filter associated with the spike was not working.As a result, leaks were observed as well as overpressure inside the bottle causing projection inside the enclosure when the spike is removed from the bottle.The drugs involved were paclitaxel, etoposide, and docetaxel (fairly viscous chemotherapy).Additionally, the customer stated there was an unprotected exposure to chemotherapy causing the contamination of the preparer (gloves, jacket), the bottle to be discarded each time (financial loss), changing of gloves, changing the sterile field and cleaning the laminar flow chamber.The spill was cleaned per protocol.No further information was provided.The customer reported four incidents.This report captures the third of four incidents.
Additional Manufacturer Narrative
D10 - date returned to mfg: 11/16/2020.H10: the new ch-74-10 locking universal vented vial spikes were functionally tested while following the directions for use.There was no leakage observed during withdrawal or reinfusion of the sterile water from and back into the drug vial.The lot review was performed with no issues noted.The complaint was unable to be replicated or confirmed.

• Brand Name: LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS
• Common Device Name: SYRINGE, PISTON
• 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: 10528997
• Report Number: 9617594-2020-00390
• Device Sequence Number: 2902617
• Product Code: FMG
• UDI-Device Identifier: 00840619065706
• UDI-Public: (01)00840619065706(17)240701(10)4165901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 07/01/2024
• Device Catalogue Number: CH-74-10
• Device Lot Number: 4165901
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DOCETAXEL, MFR UNK; ETOPOSIDE, MFR UNK; PACLITAXEL, UNK MFR; UNSP SYRINGE, UNK MFR; DOCETAXEL, MFR UNK; ETOPOSIDE, MFR UNK; PACLITAXEL, UNK MFR; UNSP SYRINGE, UNK MFR