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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. MICROCLAVE® NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 12568
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Manufacturer Narrative
One new sample (b)(4) was returned by the customer for complaint investigation.As received, there was no physical damage and no anomalies were observed.No mating device was returned.The sample was tested as per procedure finding and no internal or external leaks were identified after testing.The male luer iso meet product design specification.Without the return of the used set or the mating device, the customer's complaint could not be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
 
Event Description
The complaint/event involved a microclave® neutral connector that reportedly spun/popped off of the male luer at the distal end of a bd primary tubing set during a tpn (total parental nutrition) infusion at approximately 2:00 pm.The microclave was connected to the end of the picc line where they would normally have it.This caused a leaking issue and concern for the vascular team at the facility.There was no adverse event and no one was harmed as a result of the reported event.
 
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Brand Name
MICROCLAVE® NEUTRAL CONNECTOR
Type of Device
SET, 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
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18825739
MDR Text Key336770860
Report Number9617594-2024-00227
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00887709042377
UDI-Public(01)00887709042377(17)261101(10)5713150
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970855
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
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12568
Device Lot Number5713150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNSPECIFIED PRIMARY TUBING SET, MFR BD; UNSPECIFIED TPN (TOTAL PARENTAL NUTRITION), MFR UK
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