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

Lot Number 4186599

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2022

Event Type  Injury  

Event Description

It was reported that the epidural catheter broke off during insertion.Uneventful epidural needle insertion and catheter advancement through needle.Blood was observed coming back through catheter and catheter removed.[approximately] 5 cm piece was found to be missing from the catheter tip.Currently, the patient appears to have suffered no harm, though it is currently unclear where the "lost" 5cm is ? it has not been possible to locate this through imaging techniques etc.Additionally, it was also reported that the patient was discharged.So far there appears to be no negative repercussions of this incident, also imaging was performed however the broken piece was not able to be identified in this process.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.E4 is unknown, no information provided to date.

Manufacturer Narrative

H10: device evaluation: one used decontaminated catheter sample was returned without its original packaging to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that 5cm of the catheter tip is missing.Based on the shape of the cut area we can confirm that a sharp object cut off the catheter.During manufacturing, each catheter is quality checked and visibly inspected under magnification.A detection mechanism is in place making it improbable that a catheter which is cut would pass through those inspections.Based on the condition of the returned sample, the root cause would be attributed to user interface whereby the catheter was most probably cut off during use by a sharp tool.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: d10: correction: device available for evaluation: updated.

• Brand Name: PORTEX EPIDURAL CATHETER
• 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: 15188567
• MDR Text Key: 297487843
• Report Number: 3012307300-2022-14993
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4186599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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