MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 8.0MM, BOX/10, CASE/100

Model Number I-PFTVVC-80

Device Problems Infusion or Flow Problem (2964); Unintended Deflation (4061)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

After 2 weeks of intubation, the inflation tube fell out.

Manufacturer Narrative

Interruption in therapy caused the patient to be re-intubated.Patient involvement as the inflation tube falling out could cause hypoxia.

Manufacturer Narrative

Interruption in therapy caused the patient to be re-intubated.Patient involvement as the inflation tube falling out could cause hypoxia.Complaint confirmed with photos.Perform risk analysis with rma-20024b determined a severity rating of 6.Reviewed complaint history for the 24 months preceding the complaint reporting date and determined no trending issue.Sent root cause investigation from the supplier with complaint resolution to the customer.

Event Description

After 2 weeks of intubation, the inflation tube fell out.

• Brand Name: SALTER LABS
• Type of Device: TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 8.0MM, BOX/10, CASE/100
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16401788
• MDR Text Key: 309960645
• Report Number: 3000219639-2023-00005
• Device Sequence Number: 1
• Product Code: BSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I-PFTVVC-80
• Device Catalogue Number: I-PFTVVC-80
• Device Lot Number: INKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other