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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8371
Medical Device Problem Code Disconnection (1171)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The event occurred on an unspecified date, further described as over the "last few weeks".Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that the tubing of an one-link non-dehp y-type microbore catheter extension set disconnected (tubing separated from the male luer).This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that the male luer lock came apart from the tubing.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12423806
Report Number1416980-2021-05446
Device Sequence Number3420758
Product Code FPA
UDI-Device Identifier00085412091822
UDI-Public(01)00085412091822
Combination Product (Y/N)Y
Initial Reporter CountryCA
PMA/510(K) Number
K132734
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 10/07/2021
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
Operator of Device Health Professional
Device Catalogue Number7N8371
Device Lot NumberDR20K12017
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/11/2021
Supplement Date Received by Manufacturer10/05/2021
Initial Report FDA Received Date09/03/2021
Supplement Report FDA Received Date10/07/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/13/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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