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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 Code Contamination (1120)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a bulk package of fifty wrapped one-link non-dehp standard bore catheter extension sets had a contamination issue.It was further described as a bug had laid eggs in the package that wrapped the fifty extension sets.It was further stated that the packaging remained unopened and the bugs were seen through the clear wrapping that held the sets together.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, and h6.H4: the lot was manufactured from february 25, 2021- february 26, 2021.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a small bug inside the packaging wrapping; however, not inside the product itself.The reported condition was verified.The cause of the reported condition was a manufacturing issue.A nonconformance has been opened to address this issue.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 Key12207497
Report Number1416980-2021-04484
Device Sequence Number4487260
Product Code FPA
UDI-Device Identifier00085412475400
UDI-Public(01)00085412475400
Combination Product (Y/N)Y
Initial Reporter StateNY
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
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/26/2021
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 Other
Device Catalogue Number7N8391
Device Lot NumberR21B25065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Initial Date Received by Manufacturer 06/28/2021
Supplement Date Received by Manufacturer08/24/2021
Initial Report FDA Received Date07/21/2021
Supplement Report FDA Received Date08/26/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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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