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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 7N8391
Medical Device Problem Codes Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/16/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that two (2) one-link non-dehp standard bore catheter extension sets were leaking at the connection site with the hub of the angiocatheters.It was further stated that the connection loosens which resulted in an iron leak and blood leak back from the angiocatheter.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
Additional information was added to h4, h6 and h10.H4: the lot was manufactured from april 26, 2021 - april 27, 2021.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.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 Key12313118
Report Number1416980-2021-04961
Device Sequence Number11554572
Product Code FPA
UDI-Device Identifier00085412475400
UDI-Public(01)00085412475400
Combination Product (Y/N)Y
Initial Reporter CountryUS
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,health
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 09/14/2021
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 Number7N8391
Device Lot NumberR21D24189
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/19/2021
Supplement Date Received by Manufacturer09/10/2021
Initial Report FDA Received Date08/12/2021
Supplement Report FDA Received Date09/14/2021
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 N
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ANGIOCATHETER; ANGIOCATHETER
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