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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. 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-H1225
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
The customer indicated that the device was discarded.A representative device from the same lot is expected to be returned for investigation.It has not yet been received.
 
Event Description
The event involved a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave®, luer check valve that the customer reported a leak of an unspecified chemotherapy drug onto the nurse's forearm during connection to a patient as result of the clamp spontaneously unclamping from the extension set.Prior to the event, the extension was primed and clamped by the preparers in the pharmacy.The customer reported that their procedures instruct them to prime the tubing and then clamp it in order to be able to change the cap.The customer reported they have implemented corrective actions where the pharmacy team systematically checks the clamping before release and the nurses must check the clamping prior to opening the bag that contains the infusion bag.The device was not replaced and no further problem encountered.There was patient involvement and although there was a report of unprotected chemotherapy exposure to the nurse, there was no harm reported, no serious injury, no blood loss, no delay in therapy, no negative consequences to the operator, no clinical consequence to the patient, and no need for medical intervention.This captures the second of three events reported.
 
Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The dhr for lot number 4960976 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information that has been provided.Additional information can be found in d9.
 
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Brand Name
41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK
Type of Device
STOPCOCK, I.V. SET
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 Key11255145
MDR Text Key234474248
Report Number9617594-2021-00021
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00840619007843
UDI-Public(01)00840619007843(17)250801(10)4960976
Combination Product (y/n)N
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-H1225
Device Lot Number4960976
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNSPECIFIED CHEMOTHERAPY (MFR UNK)
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