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

Model Number	CL-10-5
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	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) list# cl-10-5, chemolock¿ bag spike, 5 units.Lot# 4593069, one (1) unit list# cl-10-5, and one (1) used container 0.9% sodium chloride injection, usp, manufacturer baxter were received for evaluation.The reported complaint of bag spike breaks causing a leak was confirmed on one of the sample of the 5 returned.During visual inspection, the poppet of the chemoport bag spike was found broken on sample-5.The returned bag spike samples (5) were primed and pressure leak tested in an un-activated state, a leak was observed on sample-5 of the chemoport bag spikes.This leak had occurred due to the broken poppet in the bag spike.The probable cause of the broken poppet was not determined.A device history review for lot# 4593069 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involves a chemolock bag spike that when attaching the syringe to the bag spike, the spike breaks into pieces causing the liquid to leak.The technician was disconnecting an unspecified syringe with a cl2000s chemolock attached from a 250ml normal saline bag with the device attached.Once the two were detached, unspecified chemo infused normal saline splashed all over the hood and into the technician.No other information was provided.

• Brand Name: CHEMOLOCK BAG SPIKE, 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
• MDR Report Key: 10266743
• Report Number: 9617594-2020-00234
• Device Sequence Number: 3066264
• Product Code: ONB
• UDI-Device Identifier: 00887709071018
• UDI-Public: (01)00887709071018(17)250201(10)4593069
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• 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
• Report Date (Section B): 05/26/2020

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: 02/01/2025
• Device Model Number: CL-10-5
• Device Catalogue Number: CL-10-5
• Device Lot Number: 4593069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1