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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. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Model Number 42800-39
Device Problems Disconnection (1171); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
 
Event Description
The event occurred on an unspecified date and involved a transpac¿ it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve.The reporter stated that a picu/nicu experienced a disconnect of the intravenous (iv) administration extension set at the bonding point on their transpac it transducer.There was no patient involvement or patient harm reported.
 
Manufacturer Narrative
The reported complaint of separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the pvc tubing was found separated from the transducer luer pocket.The pvc tubing was observed to be tacky.The probable cause of the pvc tubing being tacky was due to the tubing not being fully cured during assembly.
 
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Brand Name
TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key15805717
MDR Text Key307166589
Report Number9617594-2022-00302
Device Sequence Number1
Product Code DRS
UDI-Device Identifier00887709098169
UDI-Public(01)00887709098169(17)250901(10)8602165
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052828
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/27/2022
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 Model Number42800-39
Device Catalogue Number42800-39
Device Lot Number8602165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/16/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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