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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. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MC33131
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
The event involves a 7" (18 cm) appx 0. 43 ml, pressure infusion (400psig) ext set w/microclave® clear, purple clamp, rotating luer that the customer stated the hospital is having issues with prefilled syringes of naloxone made by dr. Reddy's and auromedics. The syringe barrels appear to be very similar in design. The issue arises when the syringe is attached to the set, the small plastic tube in the extension set becomes lodged in the fluid path of the syringe and breaks off. Additionally, the customer reported the timeliness of the administrations and the loss of intravenous lines due to the broken j-loops. There was patient involvement, however, no report of harm. This captures the second of three events reported.
 
Manufacturer Narrative
The device was not returned for evaluation. Without the returned device a probable cause is unable to determined.
 
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Brand Name7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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 Key13265432
MDR Text Key294657871
Report Number9617594-2022-00004
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMC33131
Device Catalogue NumberMC33131
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/17/2022 Patient Sequence Number: 1
Treatment
NALOXONE PREFILLED SYRINGE, AUROMEDICS MFR; NALOXONE PREFILLED SYRINGE, DR. REDDY MFR
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