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

Catalog Number NEPI-NLD-49652-25

Device Problem Fracture (1260)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/16/2018

Event Type  Injury  

Event Description

It was reported that a patient was sitting in an upright position when an anesthesiologist inserted a needle and a piece of it broke off and remained in the patient.The patient required surgery to remove the piece of broken needle, which was successfully removed and the patient was discharged without further complication.

• Brand Name: PORTEX® PENCIL POINT SPINAL ANESTHESIA 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 ; 7633833310
• MDR Report Key: 7523536
• MDR Text Key: 108568845
• Report Number: 3012307300-2018-01575
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 35019517114649
• UDI-Public: 35019517114649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: NEPI-NLD-49652-25
• Device Lot Number: 3596453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR