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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

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EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N1333
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during the unspecified date of (b)(6) 2021.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that four (4) non-dehp standard bore catheter extension sets were block/clogged.It was further reported that it was impossible to empty the set unless by injecting liquid with an unspecified syringe by applying strong pressure on the plunger.This was identified during/after use (not further specified).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: four (4) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed as follows, remove protector, ensure slide clamp is open, prime set, purge air, attach male luer until secure, open and close slide clamp as required.Additionally, clear passage and pressure tests were performed on the samples.As a result, the clear passage test failed in three (3) units and the pressure test could not be performed in the three units due to the clear passage test failure.The reported condition was not verified on one of the samples however, the reported condition of no flow was verified on the other three (3) samples.The cause of the condition was determined to be a machine related issue during the manufacturing process.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
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12456949
MDR Text Key271015348
Report Number1416980-2021-05610
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412475394
UDI-Public(01)00085412475394
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,foreig
Type of Report Initial,Followup
Report Date 10/13/2021
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
Device Operator Other
Device Catalogue Number2N1333
Device Lot NumberUR21D21029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Initial Date Manufacturer Received 08/17/2021
Initial Date FDA Received09/10/2021
Supplement Dates Manufacturer Received10/07/2021
Supplement Dates FDA Received10/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2021
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 SYRINGE
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