MAUDE Adverse Event Report: SMITHS MEDICAL, INC., PORTEX® EPIDURAL MINIPACKS; EPIDURAL KIT

Catalog Number 100/391/116

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the product sample.The investigation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Once the product evaluation has been performed, the manufacture will file a follow-up report detailing the results.

Event Description

A report was received indicating that an epidural catheter was placed in a patient, and upon removing the catheter, the tip was observed missing.The catheter tip is believed to have become severed and remained in the patient.An x-ray, ct scan, mri and usg were performed to locate the fragmented catheter tip, but the piece was not found.No permanent injury was reported.

Manufacturer Narrative

One used sample was returned for evaluation.The length was measured and found to be missing a 4.55 mm piece of catheter.Under visual inspection it was noted that the epidural catheter appeared to be cut by a sharp tool, most likely the tuohy needle.The failure was attempted to be simulated on reserved samples and the shape of cut was able to be simulated.Most likely the epidural catheter detached due to improper handling of the component.

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): SMITHS MEDICAL, INC.,; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL, INC.,; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5068192
• MDR Text Key: 25418209
• Report Number: 2183502-2015-00658
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1