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

Model Number 100/382/116

Device Problems Material Fragmentation (1261); Device Contamination with Body Fluid (2317)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Udi is unknown.No information has been provided to date.A device history record (dhr) 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.The investigation of the complaint was limited because no sample was returned, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the patient was admitted to the institution to undergo a lipoabdominoplasty surgical procedure.Anesthetic block was performed with a 16g tuohy needle, t8 t9, loss of resistance technique, test dose, anesthetic infiltration without intercurrence.Passage of epidural catheter.Needle removal without complications.Afterwards, blood was returned through the catheter, a small indentation of 0.5 cm was made and the catheter was washed with lidocaine with a vessel.Aspiration of the catheter was performed and the return of the anesthetic slightly stained with blood was observed, at this moment the patient made an extension movement of the spine, after which the change in the position of the catheter was noticed and after slight manipulation it was observed that it had broken in the marking "3" of the catheter.An attempt was made to remove it by making a 3 cm incision in the skin over the puncture site to see if it was in the subcutaneous tissue, but nothing was found.The case was discussed with a neurosurgeon and it was decided to proceed with the procedure under general anesthesia and monitor the evolution of the ruptured catheter portion.

• Brand Name: PORTEX EPIDURAL CATHETERS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15826058
• MDR Text Key: 303927818
• Report Number: 3012307300-2022-27318
• 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: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/382/116
• Device Catalogue Number: 100/382/116CZ
• Device Lot Number: 4099003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female