MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ CLOSED VIAL SPIKE W/SKIRT, 5 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL-80S-5
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - device has been returned.Investigation is pending completion.
Event or Problem Description
A complaint with regards to chemolock¿ closed vial spike w/skirt, 5 units experienced foreign matter in the fluid path.It was reported that "bendeka was withdrawn from two vials, each containing a cl-80s-5, from the lot mentioned.It was withdrawn into a 10ml syringe with cl2000s.White particulate was noticed by the pharmacist and technician, who thought it was coring although the stopper was dark grey.A cl2100 was attached to the cl2000s on the syringe and a filter needle to the cl2100 and infused the medication into the bag filtering out the particulate matter.The matter should be somewhere in the needle, cl2100, cl2000s or syringes".The sample device is available for evaluation.The product was contaminated, contained biohazard, and chemotherapeutic agent.The date of incident was on (b)(6) 2024 at 9:00 a.M.The status of the product at the time of the event was during compounding prior to infusing into bag.The medication involved was bendeka.The product was not reprocessed or re-sterilized prior to use.There was no patient involvement, no adverse event and there was no harmed as a result of the reported event.
Additional Manufacturer Narrative
Received two used units.List #cl-80s-5, chemolock¿ closed vial spike w/skirt, 5 units.Two (2) used.List #unknown, bendeka (bendamustine hci) injection 100 mg/4 ml teva pharmaceuticals multi-dose vial.As received, there were small particles floating in the solution in the vials.Removed the vial lid/stopper and noted evidence of material removed.Customer complaint of white particulate cannot be confirmed.Grey particulate noted, probable cause, coring from the bendeka stopper.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOLOCK¿ CLOSED VIAL SPIKE W/SKIRT, 5 UNITS
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20272108
• Report Number: 9617594-2024-01320
• Device Sequence Number: 3505311
• Product Code: ONB
• UDI-Device Identifier: 00887709077119
• UDI-Public: (01)00887709077119(17)270601(10)6026346
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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 Catalogue Number: CL-80S-5
• Device Lot Number: 6026346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENDEKA , TEVA PHARMACEUTICALS
• Patient Sex: Unknown