Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ; PENCAN SPINAL NEEDLE TRAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL INC. ; PENCAN SPINAL NEEDLE TRAY Back to Search Results
Lot Number 0061517708
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/19/2017
Event Type  Injury  
Event Description
Pt was scheduled for a right total knee replacement and in the process of getting the epidural, the distal portion of pencan 27g spinal needle broke off during attempt at spinal placement.Stylette intact.X-ray shows retained needle piece next to l4 pedicle.Neurosurgery team planned immediate removal of spinal needle piece under general anesthesia.Laminectomy ensued.Needle tip found with fluoroscopy guidance, removed and sent to pathology.Pt did not get scheduled rtkr.Post op care ensued and pt was discharged home on (b)(6) 2017 in stable condition.Occurrence reported to (b)(6) through (b)(6) under code 913ne.Diagnosis or reason for use: epidural.Is the product compounded: no.Is the product over-the-counter: no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
PENCAN SPINAL NEEDLE TRAY
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key6279047
MDR Text Key65970698
Report NumberMW5067466
Device Sequence Number1
Product Code BSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/24/2017
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? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Lot Number0061517708
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2017
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight95
-
-