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

Catalog Number 24-1301-22

Device Problems Fracture (1260); Stretched (1601)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that a senior trainee was needed to re-site an epidural that had initially failed on a patient.Upon closer inspection, the clip-lock used to secure the epidural catheter in place on the patient's back had caused the catheter to shear in two.Multiple areas of stretching and damage along the catheter were noted as well.Customer states that they feel the catheter was too fragile for its intended purpose.Customer has withdrawn the stock from clinical use as a precautionary measure.No patient harm.

Manufacturer Narrative

Other text: d4: udi number, no information 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.

Manufacturer Narrative

Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One used device was received without its packaging.Under visual inspection it was noticed that the catheter was stretched and cut into two parts (full catheter length was received).The complaint was confirmed.The most probable root cause was that the customer did not follow instructions for use in which the catheter was stretched during use and led to its cut.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No further action was taken as the root cause was due to user mishandling.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17608017
• MDR Text Key: 321837489
• Report Number: 3012307300-2023-08368
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-1301-22
• Device Lot Number: 4095336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1