MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS; ANESTHESIA CONDUCTION KIT

Catalog Number 928/118/0008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Headache (1880)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a portex® csecure® spinal and epidural needle assembly - minipack has caused a headache for an obstetric patient prolonging the patient's stay.The patient suffered an intense headache.No medical intervention was needed.

• Brand Name: PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS
• 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, KEENE; 10 bowman drive; keene NH 03431
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7643432
• MDR Text Key: 112515647
• Report Number: 3012307300-2018-02519
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 928/118/0008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization