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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
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event 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.
 
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
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12207497
MDR Text Key262901319
Report Number1416980-2021-04484
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412475400
UDI-Public(01)00085412475400
Combination Product (y/n)Y
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8391
Device Lot NumberR21B25065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Date Manufacturer Received08/24/2021
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 Sequence Number1
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