MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ VIAL SPIKE, 20MM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL-80S
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date, a chemolock¿ vial spike, 20mm would not aspirate fluids.The clinician stated that when a 20 mm spike was connected to a vial of sterile water (10 ml) they were able to withdraw liquid.However, only 8 ml was able to be withdrawn.For some reason, fluid entered the vial spike¿s air vent (balloon) so there was a loss of about 2 ml.A sample photo was provided showing the defective product.The sample is available for evaluation.There was no patient harm reported.
Additional Manufacturer Narrative
Received one (1) new cl-80s chemolock vial spike and one (1) used cl-80s chemolock vial spike connected to a vial and 10 ml syringe with chemolock.The side port balloon on the used set was deployed.No defects or anomalies noted.When functionally tested according the dfu instructions there was no leakage observed or replicated on either set.The reported complaint was unable to be replicated or confirmed.A lot history were reviewed and no relevant non-conformities were found that would have led to the reported complaint.

• Brand Name: CHEMOLOCK¿ VIAL SPIKE, 20MM
• 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: 19591872
• Report Number: 9617594-2024-00815
• Device Sequence Number: 8566773
• Product Code: ONB
• UDI-Device Identifier: 00887709069596
• UDI-Public: (01)00887709069596(17)280301(10)13589463
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Device Lot Number: 13589463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: NORMAL SALINE, UKN MFR.
• Patient Sex: Unknown