MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL TRAY WITH DRUGS; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number NEPI-4945-18

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Lot number, expiration date, udi number and manufacture date, are unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported the department was out of "normal" epidural kits to replace epidural catheter.One of nursing students fainted and hit her head requiring emergency department (ed) visit and sterile field was compromised and replaced.Catheter wasn't threading so the physician withdrew stylet to inject saline and rethread catheter.Provider believes it sheared off and got stuck because tip didn't look the same, less markings than before.He believes it is left in the patient, doesn't show on computerized tomography (ct) but the provider doesn't think it would show.Ultrasound (us) didn't show anything.Neuro at (b)(6) advised patient will see him in a few weeks.Checking to see if it would be mri safe (tip is plastic).Patient is aware.Dr.Saved the catheter and it's in her paper chart file.

Manufacturer Narrative

Other text: h6.Health impact and evaluation codes: updated.Received for investigation, one (1) photograph containing one used catheter.The photograph revealed a partial tear at the end of the catheter, confirming the customer complaint.It is unclear as to how the catheter tore upon removal.A device history record (dhr) review could not be performed as the lot number is unknown.No further action will be taken at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.If the device is returned the manufacturer will re-open the investigation for further device analysis.

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY WITH DRUGS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16546695
• MDR Text Key: 311326991
• Report Number: 3012307300-2023-02483
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NEPI-4945-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female