MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL KIT, 16G; ANESTHESIA CONDUCTION KIT

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Pregnancy (3193)

Event Date 03/27/2013

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the device was placed in use with patient during labor.According to reporter, while the epidural kit was being placed, the catheter tip broke off and remained in patient.When patient's labor was completed, patient was examined via mri and ultrasound; the images did not locate the catheter tip.Patient was discharged from hospital care (b)(6) 2013.No further adverse health outcomes were reported.

• Brand Name: PORTEX EPIDURAL KIT, 16G
• 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: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6241164
• MDR Text Key: 64586032
• Report Number: 3012307300-2017-00184
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2016
• 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 Age: 33 YR