MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. MEDLINE; HME

Model Number DYNJAAHME10

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer allege the "blue filter moved from hme into the patient's trach.".

Manufacturer Narrative

Another supplemental mdr will be submitted once the investigation is complete.

Event Description

The customer allege the "blue filter moved from hme into the patient's trach.".

Manufacturer Narrative

On (b)(6) 2020 medline reported that their customer could not return a used sample per their internal policy.Neither medline nor sunmed was therefore able to perform an investigation on the sample specific to these complaint reports.Medline was to send a rep to the account for additional photos and information, however as of (b)(6) 2020, no additional information has been received by sunmed from medline in relation to this complaint.Based on the investigation that was conducted which included review of manufacturing, complaint trends, design, and risk, with additional failure to replicate this alleged failure mode, this complaint could not be confirmed and will be closed.

Event Description

The customer allege the "blue filter moved from hme into the patient's trach.".

• Brand Name: MEDLINE
• Type of Device: HME
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• MDR Report Key: 10438582
• MDR Text Key: 205006001
• Report Number: 1314417-2020-00021
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJAAHME10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/21/2020; 09/30/2020
• Patient Sequence Number: 1