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

Catalog Number	CH-17
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.The customer reports a same lot device sample is available for evaluation.It has not been received.
Event or Problem Description
The event involved a chemoclave® mini bag spike that was leaking an unspecified chemotherapy during infusion.It was reported that the spike of the device was connected to the bag and when the device had been in use for an hour, a leak of chemotherapy was noted from the bag and the spike was found to be cracked.The device was not changed out or replaced.The customer reported the chemoclave mini bag spike is used for the bags used in chemotherapy, stating they use a manual device to introduce the spikes.There was patient involvement and a report of unprotected chemo exposure; however, there was no serious injury or death, no blood loss, no delay in critical therapy and no adverse operator consequences.This reflects 2 of 2 events.
Additional Manufacturer Narrative
H10 - no product samples were returned for investigation, however, a photograph was returned showing a ch-17 with an axial crack at the female luer of the bag spike where it bonds to the clave connector.The device history review (dhr) was reviewed and there were no non-conformances found that would have contributed to the reported complaint.The complaint was confirmed, however, without the return of the affected sample a probable cause cannot be determined.Additional information can be found in section d10.

• Brand Name: CHEMOCLAVE MINI BAG SPIKE
• 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: 10065132
• Report Number: 9617594-2020-00137
• Device Sequence Number: 3753074
• Product Code: ONB
• UDI-Device Identifier: 00840619033880
• UDI-Public: (01)00840619033880(17)250101(10)4603672
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 01/01/2025
• Device Catalogue Number: CH-17
• Device Lot Number: 4603672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/23/2020
• 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: UNSPEC CHEMO, MFR UNK; UNSPEC SOLUTION CONTAINER, MFR UNK