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

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Anxiety (2328); Depression (2361); Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2015

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.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 during the patient's third labor, a portex® epidural minipack failed, and the patient consequently suffered from neurological problems and pain as well as depression and anxiety.It was also noted that during the introduction of the device, blood appeared while pulling out the catheter.The catheter's tip was torn, and 7cm of it "were left inside".Additional information regarding the event and patient's condition was requested, however the reporter stated no further information is available.

• Brand Name: PORTEX® EPIDURAL MINIPACK
• 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 CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6745057
• MDR Text Key: 81086265
• Report Number: 3012307300-2017-01601
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other