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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET
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SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET Back to Search Results
Catalog Number 689128/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during the pre-procedure inspection, the device was found to be leaking.The device was replaced with a new unit.No patient injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
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Brand Name
SAFEDRAW TRANSDUCER SET
Type of Device
BLOOD PRESSURE TRANSDUCER SET
MDR Report Key12580006
MDR Text Key275045330
Report Number8020616-2021-00063
Device Sequence Number1
Product Code DSK
UDI-Device Identifier04589731125085
UDI-Public4589731125085
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/07/2021
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 Health Professional
Device Expiration Date04/03/2024
Device Catalogue Number689128/JPA
Device Lot NumberC2152212S1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/07/2021
Initial Date FDA Received10/05/2021
Supplement Dates Manufacturer Received10/20/2021
Supplement Dates FDA Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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