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

Catalog Number 100/382/118

Device Problem Material Fragmentation (1261)

Patient Problems Neuropathy (1983); Foreign Body In Patient (2687)

Event Date 06/14/2022

Event Type  Injury  

Manufacturer Narrative

Udi section is unknown, no product 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 additional reportable information becomes available.

Event Description

It was reported that a patient underwent hernioplasty and the anesthetist positioned the patient in a sitting position, preparing the path of the epidural puncture needle.When introducing the needle in l1-l2, clinician performed the epidural puncture according to the hanging drop technique, without intercurrences.8 cm of the epidural catheter was introduced through the connector, but there was resistance and difficulty in regressing only the catheter.When removing the whole set, a rupture of about 7 cm of the catheter was observed.With the possibility of the object remaining in the patient's body, the surgery was suspended and an mri was performed on (b)(6), but no foreign body was visualized in the imaging exams.The medical team hypothesized that the tip of the catheter was stuck inside the needle, but it was not possible to prove it.On (b)(6), the patient was discharged from the hospital with the only complaint of tingling in the feet.

Manufacturer Narrative

Conclusion codes: updated h10 device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.This failure seems to be the most probably caused by customer due to not following instructions for use.No trend of confirmed customer complaints was identified.

• 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: 16622044
• MDR Text Key: 312099428
• Report Number: 3012307300-2023-03041
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/382/118
• Device Lot Number: 3968173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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