• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL TRAY ANESTHESIA CONDUCTION KIT

  • 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
 

SMITHS MEDICAL ASD, INC. PORTEX SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number NEPINLD15248C22/25
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Infiltration into Tissue (1931); Foreign Body In Patient (2687)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation: one non-original carton containing a bag with a used and decontaminated spinal needle as well as six unopened trays for product with the same lot were received for investigation. A dhr review was completed for the product and no issues were found. Immediate visual inspection of the complaint (used) sample revealed that the cannula and a needle hub were not connected. No defects or anomalies were observed on any of the unused samples. No marks along the cannula were observed. It also revealed the hub end of the complaint cannula was damaged. The look of the damaged end was indicative of a cannula which had been bent severely to either side until completely broken from the hub. The cannula was also noticeably bent along its axis, near the center, indicating that it had received undue forces. The hub portion of the needle appeared to be undamaged. The glue cone was still intact within the hub. The glue cone retained a small portion of the needle cannula, thus confirming the complaint for breakage of the needle. Inspection of each fragment using magnification, revealed what appeared to be tool marks near the broken end of the cannula. In addition, the six unopened samples were tested for resistance to breakage and no breakage was observed on any of the samples. All samples passed the breakage test without issue. Furthermore, a straight portion of the used cannula was removed and was tested for breakage in the same manner and used cannula remained intact. No sign of breakage was observed. This testing determined that the cannulas of the used and unused samples of the spinal needle (ne588), successfully met the requirements of the above standard for resistance to breakage. All cannulas functioned as intended. The issue observed by the customer could not be reproduced during this investigation, but the complaint allegation was confirmed due to the evidence of the complaint sample damage. The root cause is noted as unknown.
 
Event Description
Information was received that when an experienced crna was removing a smiths medical portex spinal tray spinal needle from a patient, the needle broke off at the hub. The image of the needle "did not show up well on fluoroscopy" and the physician stated "the tip may have been stuck in the bone or between vertebrae". Subsequently, surgical removal of the needle was required. It was noted the needle "got pretty deep and had moved considerably". No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX SPINAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8402289
MDR Text Key138204883
Report Number3012307300-2019-01276
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E332605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2020
Device Model NumberNEPINLD15248C22/25
Device Catalogue NumberNEPINLD15248C22/25
Device Lot Number3644576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/07/2019 Patient Sequence Number: 1
-
-