MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX LUMBAR PUNCTURE TRAY CHILD/INFANT; ANESTHESIA CONDUCTION KIT

Catalog Number 4826PL-20

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

A photo was received to perform an investigation.The photo showed two trays and the box with label.The label of one of the trays was fully visible and verified that the tray tyvek label was incorrect.The photo revealed that the bottom corner of the tyvek label and the shipper label contained correct part numbers.Based on the evidence, the problem for incorrect box labels was not confirmed; however, the investigation identified the problem with the tray tyvek label.The problem source was consistent with the human factor during the print plate set up at the time of lot changeover, and it was not detected during subsequent inspection and final release of the lot.A device history record (dhr) review was conducted and confirmed that the part number on the tray label upper left corner was incorrect.It did not match the bill of material for product lot.The dhr review did confirm that the carton label contained the correct part number.A corrective and preventive action (capa) was initiated to further investigate the problem and determine the appropriate actions.A labeling problem was confirmed and the root cause was determined to be related to manufacturing.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the customer received two mislabeled cases.The product was correct but the boxes were labeled incorrectly.No patient injury was reported.

• Brand Name: PORTEX LUMBAR PUNCTURE TRAY CHILD/INFANT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 15461732
• MDR Text Key: 306321576
• Report Number: 3012307300-2022-19943
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 4826PL-20
• Device Lot Number: 3842192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1