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

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.

• Brand Name: PORTEX SPINAL TRAY
• Type of Device: ANESTHESIA 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 Key: 8402289
• MDR Text Key: 138204883
• Report Number: 3012307300-2019-01276
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 35019517115585
• UDI-Public: 35019517115585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E332605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: NEPINLD15248C22/25
• Device Catalogue Number: NEPINLD15248C22/25
• Device Lot Number: 3644576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention