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: 7716395
• MDR Text Key: 114929925
• Report Number: 3012307300-2018-02914
• 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: Physician
• 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: Health Professional
• 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
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention