MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK BAG SPIKE, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL-10-10
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Patient Involvement (2645)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is not yet complete.
Event or Problem Description
The event involved a chemolock¿ bag spike, 10 units that the customer reported leaking.The unknown hazardous drug leaking was noticed during priming for 1 hour at 9:00 am.The customer stated that no drug was lost, however, fluid dripped out upon disconnecting to dispose of the bag, exposing the hazardous drug.When the chemolock injector was disconnected from the chemolock bag spike the residual in the bag spilled out onto the floor, exposing the hazardous drug.There was no patient involvement, no adverse event, and no delay in therapy.
Additional Manufacturer Narrative
One used list# cl-10-10 (1 unit), chemolock¿ bag spike, 10 units.Lot# 4775039 and one used container 0.9% sodium chloride injection 100 ml, usp, manufacturer baxter.One (1) used list# cl-10-10 (1 unit), chemolock¿ bag spike, 10 units.Lot# 4775039 were received for evaluation.Two used cl-10-10 chemolock bag spikes were confirmed with the tip of the chemolock port post spikes broken off.The probable cause of the broken chemolock spike is due to an automated assembly error.A device history review (dhr) lot# 4775039 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: CHEMOLOCK BAG SPIKE, 10 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: 10337927
• Report Number: 9617594-2020-00270
• Device Sequence Number: 3065019
• Product Code: ONB
• UDI-Device Identifier: 00887709071025
• UDI-Public: (01)00887709071025(17)250401(10)4775039
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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 Model Number: CL-10-10
• Device Catalogue Number: CL-10-10
• Device Lot Number: 4775039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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: CHEMOLOCK INJECTOR, MFR UNK; CHEMOLOCK INJECTOR, MFR UNK