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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

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EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number T001691A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.
 
Event Description
It was reported that after opening the package, in this pressure monitoring set, it was discovered that there was liquid inside the dip chamber.The device was replaced.There was no allegation of patient injury.The device was available for evaluation.Since this was before use, patient demographics are not available.
 
Manufacturer Narrative
One single dpt with vamp plus was received for evaluation.The reported event of liquid inside the drip chamber was not confirmed.Paper tapes were noted on iv tubing.Visual examination of the kit both before and after decontamination did not find any presence of foreign substance or liquid inside the kit.Kit was tried to be drained, no foreign substance or liquid came out on filter paper from draining.Finally, returned kit was primed and flushed without any indication of flow restriction or occlusion.Flush device functioned properly during priming and flushing.No visible damage was observed from the kit.A device history record review was completed and documented that device met all specifications upon distribution.Since the defect was not confirmed, no corrective actions will be taken at this time.
 
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Brand Name
PRESSURE MONITORING SET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR 
MDR Report Key11113633
MDR Text Key227070202
Report Number2015691-2021-00009
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/16/2020
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 Health Professional
Device Expiration Date07/20/2022
Device Model NumberT001691A
Device Lot Number63317142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received01/13/2021
Supplement Dates FDA Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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