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U.S. Department of Health and Human Services

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

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE MINI BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
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.
 
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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 Key10065132
MDR Text Key202024361
Report Number9617594-2020-00137
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00840619033880
UDI-Public(01)00840619033880(17)250101(10)4603672
Combination Product (y/n)N
PMA/PMN Number
K173477
Number of Events Reported1
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 NumberCH-17
Device Lot Number4603672
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/30/2020
Initial Date FDA Received05/18/2020
Supplement Dates Manufacturer Received06/03/2020
Supplement Dates FDA Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNSPEC CHEMO, MFR UNK; UNSPEC SOLUTION CONTAINER, MFR UNK
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