SHILEY 8PERC 8 PERC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for SHILEY 8PERC 8 PERC manufactured by Covidien.

Event Text Entries

[173658124] Shiley #8perc tracheostomy tube was placed on (b)(6) 2019 at 21:29 via percutaneous procedure using bronchoscopy by (b)(6). On (b)(6) 2019 respiratory therapist was called to patient bedside by rn and noted that the top part of the trach flange had separated from the tracheostomy tube. Patient currently on mechanical ventilation with no loss of volume. The patient had coagulation issues and there was bleeding at the trach site. Sutures were placed around the trach site by (b)(6), and a decision was made to replace the trach tube next day due to coagulation issues. On (b)(6) 2019 at 12:58 the tracheostomy tube was changed via bronchoscopy with a size 6 dct. Respiratory therapist was told by another nurse of a similar event on another patient where an 8perc trach was cracked in the same place and was changed to a 6dct. It was also discovered that another respiratory therapist has had at least 2 other perc trachs that were cracked on insertion. None of these tracheostomy tubes were saved or reported. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5091985
• MDR Report Key: 9539827
• Date Received: 2019-12-31
• Date of Report: 2019-12-30
• Date of Event: 2019-12-23
• Date Added to Maude: 2020-01-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SHILEY 8PERC
• Generic Name: TRACHEOSTOMY, TUBE (W/WO CONNECTOR)
• Product Code: BTO
• Date Received: 2019-12-31
• Model Number: 8 PERC
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-12-31