MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SWAB,ORAL,DENTIPS,TREATED,GREEN,10/PK

Catalog Number MDS096504

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a nurse was doing oral care on an inpatient hospitalized intubated patient when the patient clenched their jaw, resulting in a piece of the sponge coming off in the patient's mouth.The patient did not have a bite block in place per manufacturer's instructions.The patient's airway was almost occluded when two other nurses attempted to and ultimately succeeded in retrieving the broken sponge from the patient's mouth without further incident.No further intervention was required.The actual sample involved in the incident was discarded and is not available to be returned for evaluation however companion samples were available from the same box/lot.The sample evaluation determined that there was sufficient glue coverage on the sponge and use of a bite block is recommended on the product packaging therefore this complaint is determined to be customer caused due to no bite block in use at the time of the event.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a client clamped down on the dentips and the whole foam piece became disconnected from the stick in the clients mouth.

• Type of Device: SWAB,ORAL,DENTIPS,TREATED,GREEN,10/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 12414751
• MDR Text Key: 272473944
• Report Number: 1417592-2021-00172
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2021

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 Catalogue Number: MDS096504
• Device Lot Number: 21071F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention