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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Lot Number 0061780058
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/21/2021
Event Type  Injury  
Event Description
Spinal needle broke off in pt's back during removal.
 
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Brand Name
PENCAN SPINAL NEEDLE TRAY
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
MDR Report Key12253257
MDR Text Key264494689
Report NumberMW5102866
Device Sequence Number1
Product Code BSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number0061780058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/29/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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