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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX PENCIL POINT SPINAL NEEDLE SETS (WHITACRE); NEEDLE, SPINAL, SHORT TERM
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NULL PORTEX PENCIL POINT SPINAL NEEDLE SETS (WHITACRE); NEEDLE, SPINAL, SHORT TERM Back to Search Results
Catalog Number 100/496/126
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2022
Event Type  malfunction  
Event Description
It was reported when inserting the needle for a spinal anesthesia, the needle broke in two pieces and one stayed in patient's spine.Broken needle piece was removed and checked using an image intensifier.No further clinical consequence.
 
Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Further investigation will be conducted by the supplier, tae-chang industrial co.Ltd.
 
Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Further investigation will be conducted by the supplier, (b)(4) co.Ltd.
 
Event Description
It was reported when inserting the needle for a spinal anesthesia, the needle broke in two pieces and one stayed in patient's spine.Broken needle piece was removed and checked using an image intensifier.No further clinical consequence.
 
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Brand Name
PORTEX PENCIL POINT SPINAL NEEDLE SETS (WHITACRE)
Type of Device
NEEDLE, SPINAL, SHORT TERM
Manufacturer (Section G)
NULL
MDR Report Key13579211
MDR Text Key285951208
Report Number3012307300-2022-03820
Device Sequence Number1
Product Code MIA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number100/496/126
Device Lot Number4178355
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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