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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK MEDICAL SYSTEMS SPROTTE CANNULA; NEEDLE, CONDUCTION, ANESTHETIC
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PAJUNK MEDICAL SYSTEMS SPROTTE CANNULA; NEEDLE, CONDUCTION, ANESTHETIC Back to Search Results
Catalog Number 001151-30C
Device Problem Break (1069)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 05/22/2017
Event Type  malfunction  
Event Description
Patient was admitted to labor and delivery for a c-section.During regional anesthesia placement by physician, the spinal needle broke.An approximate three inch segment of the needle remained embedded in patient's back.After completion of the c-section, the needle was successfully removed by the physician.The incision was closed with silver nitrate, surgical skin glue, and steri strips.The patient tolerated the procedure well; no complications.The incident was explained to the patient and her husband.Patient was discharged within normal/expected time frame for c-section with no complications.
 
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Brand Name
SPROTTE CANNULA
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
PAJUNK MEDICAL SYSTEMS
marco wohnig
6611 bay circle, suite 140
norcross GA 30071
MDR Report Key6646455
MDR Text Key77731535
Report Number6646455
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/01/2020
Device Catalogue Number001151-30C
Device Lot Number1141
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/01/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
Patient Age30 YR
Patient Weight129
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