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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL POWERWAND XL SINGLE; ANESTHESIA CONDUCTION KIT
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NULL POWERWAND XL SINGLE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 94112
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Event Description
It was reported that upon removal of device from right upper arm it came out at an angle.The pw infused well during his collection, but never drew.The patient reported some bleeding at home at the site of the right pw location after the 1st day of collection.
 
Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.It was found that the tubbing was kinked caused by the supplier.Dhr review was done, no issues related to the original complaint were found.
 
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Brand Name
POWERWAND XL SINGLE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key13366606
MDR Text Key284523495
Report Number3012307300-2022-01895
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number94112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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