MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TRACHEAL INTUBATION STYLET; STYLET, TRACHEAL TUBE

Catalog Number 100/120/300

Device Problem Defective Device (2588)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that when unboxing the product, only one individual package was found with a short length.No patient involvement reported.

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: udi section and g5: 510k are unknown, no information available 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.

Manufacturer Narrative

Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device was received.Per visual inspection, it was observed the package was a shorter length than other packaged products, however there is no product specification in regards package dimension.The returned device was not a short length, the dimensions for the retuned part from the customer were within specifications.No discrepancies were observed.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since current controls are adequate for the complaint reported by the customer.No trends for this failure mode were observed during complaint retrospective review.Based on the device analysis and the manufacturing line revision, it is concluded that this claim is an isolated incident for the defect reported.

• Brand Name: PORTEX TRACHEAL INTUBATION STYLET
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17783550
• MDR Text Key: 323903863
• Report Number: 3012307300-2023-09140
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/120/300
• Device Lot Number: 4355978
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1