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

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.The customer reports a same lot device sample is available for evaluation.It has not been received.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 202024361
• Report Number: 9617594-2020-00137
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00840619033880
• UDI-Public: (01)00840619033880(17)250101(10)4603672
• Combination Product (y/n): N
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: CH-17
• Device Lot Number: 4603672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC CHEMO, MFR UNK; UNSPEC SOLUTION CONTAINER, MFR UNK