MAUDE Adverse Event Report: MEDLINE INDUSTRIES; COTTON TIP APPLICATOR

Catalog Number MDS202000

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2016

Event Type  malfunction  

Manufacturer Narrative

A cotton tipped applicator broke and a patient swallowed a piece.The patient was having a strep test performed.As the physician was swabbing the patient's throat the wooden stick broke.The patient ingested approximately a ¾ inch piece including the cotton tip.An abdominal x-ray and esophagram showed the swallowed piece had passed through the jejunum.Follow up showed the patient to be passing urine and stools; patient's abdomen was soft and non-tender with no apparent signs of bowel obstruction.A sample was not returned.A root cause cannot be determined but user error may be a contributing factor.Due to the reported incident and in an abundance of caution this medwatch is being filed.Not returned.

Event Description

It was reported cotton tipped applicator broke in a patient's mouth and was ingested.

• Type of Device: COTTON TIP APPLICATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6368764
• MDR Text Key: 69019457
• Report Number: 1417592-2017-00007
• Device Sequence Number: 1
• Product Code: KXG
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2017

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: Health Professional
• Device Catalogue Number: MDS202000
• Device Lot Number: 01016010003
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Other
• Patient Age: 15 MO