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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRYOR PRODUCTS PRYOR TRIPLE CARRIER INFUSION STAND

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PRYOR PRODUCTS PRYOR TRIPLE CARRIER INFUSION STAND Back to Search Results
Model Number N/A
Device Problem Detachment Of Device Component (1104)
Patient Problems Tingling (2171); Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
Pryor products received and evaluated the device. Visual inspection identified burnt markings and the screw came loose of the duplex causing the duplex to be loose in the aluminum case which contributed to the reported condition. The device was found out of specification in relation to the event. Burnt markings found on the body of the part were a result of sparks between the live and earth polarities. The two polarities sparked because when the screws are missing on the duplex, the inlets would link inside the metal body. As a result when the end-user accidentally plugged into the inlets and the pins of the plug comes in contact with the metal body of the strip, it sparks. This was further investigated by pryor products and measures were put in place to mitigate such events. Actions were taken after this device was manufactured. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a pryor products power strip located on the underside of a triple carrier iv pole base became loose and a short occurred. It was unknown when and where or during which process step this event occurred. The nurse complained of being electrocuted and reported a tingling in his arms. The severity of injury to the nurse is unknown and it is unknown if medical intervention was provided as a result of this electrical shock occurrence. No additional information related to the event is available.
 
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Brand NamePRYOR TRIPLE CARRIER INFUSION STAND
Type of DeviceINFUSION STAND
Manufacturer (Section D)
PRYOR PRODUCTS
california CA
Manufacturer (Section G)
PRYOR PRODUCTS
1819 peacock blvd
oceanside CA 14103
Manufacturer Contact
711 park avenue
medina, NY 14103
7607248244
MDR Report Key6564246
MDR Text Key75059587
Report Number1314492-2017-00883
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number55088-1
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/12/2017 Patient Sequence Number: 1
Treatment
SPECTRUM INFUSION PUMP
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