MAUDE Adverse Event Report: SUNMED MEDLINE; HME

Model Number DYNJAAHME9

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges "the inside sponge material came loose from inside the hme and was lodged in the breathing circuit blocking the patient's airway.".

Event Description

The customer alleges "the inside sponge material came loose from inside the hme and was lodged in the breathing circuit blocking the patient's airway.".

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.

• Brand Name: MEDLINE
• Type of Device: HME
• Manufacturer (Section D): SUNMED; 2710 northridge dr. suite a; grand rapids MI 49544
• MDR Report Key: 10510142
• MDR Text Key: 221562505
• Report Number: 1314417-2020-00022
• 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
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DYNJAAHME9
• Device Lot Number: 40020030152, 40020050053
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening