MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SWAB,ORAL,DENTIPS,UNTREAT,INDV WRP,BLUE

Catalog Number MDS096202

Device Problem Separation Problem (4043)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the staff was swabbing the patient's mouth and when the patient closed their mouth the sponge separated from the stick inside of the patient's mouth.The staff was able to manually remove the swab from the patient's mouth without injury.The customer returned companion samples from the same lot for evaluation and it was determined that the root cause was of the separation was due to insufficient foam coverage down the stick.No additional information is 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 the staff was swabbing the patient's mouth and when the patient closed their mouth the sponge separated from the stick inside of the patient's mouth.

• Type of Device: SWAB,ORAL,DENTIPS,UNTREAT,INDV WRP,BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13002571
• MDR Text Key: 284010665
• Report Number: 1417592-2021-00220
• 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: 12/14/2021

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: MDS096202
• Device Lot Number: 41221070001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/14/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG