MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® EPIDURAL MAXIPACK ANESTHESIA CONDUCTION KIT

Catalog Number MAXL181

Device Problem Material Deformation (2976)

Patient Problem Headache (1880)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Four unopened sets of portex® epidural maxipack were provided for analysis in which the tuohy needle was included. The used sample was not provided. The customer's reported problem was "patient injury due to a burr in the area of the tip of the tuohy needle". The four included touhy needles were visually inspected, but no deviations were found. The tuohy needle tip was visually inspected under a microscope. No burr or deviation was detected on all 4 samples. In the device history record (dhr), there is no hint of such a failure. The quality inspection processes were reviewed and considered adequate and correct. Investigation was unable to confirm the customer's reported problem.

Event Description

It was reported that there was a patient injury due to a burr in the area of the tip of the tuohy needle from a portex® epidural maxipack. The alleged injury to the dura mater spinalis and thus necessary blood patch due to cerebrospinal fluid (csf) leak. The patient complained post-op about headaches. No other patient injury was reported.

Manufacturer Narrative

Four unopened portex® epidural maxipack kits were returned, which contain tuohy needle (b)(4), for analysis. No deviations were noted upon visual exam. A microscope was used to further investigate the tuohy needle tip; no deviations detected. Based on the evidence, the complaint was not confirmed as no fault was found.

• Brand Name: PORTEX® EPIDURAL MAXIPACK
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA DEUTSCHLAND GMBH; hauptstrasse 45-47; kirchseeon, 85614 ; GM 85614
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7716396
• MDR Text Key: 114929951
• Report Number: 3012307300-2018-02913
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2022
• Device Catalogue Number: MAXL181
• Device Lot Number: 3559357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/24/2018 Patient Sequence Number: 1