MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; APPLICATOR,COTTON-TIP,WOOD,6,STRL

Catalog Number MDS202000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) she was providing care for her tracheostomy stent with the cotton tip applicator when the tip broke off into the customer's trachea.Per the customer before the cleaning she placed the swab in a 50/50 container of hydrogen peroxide and saline.Per the customer she did not notice any issues prior to the cleaning but when rotating the swab and then pulling out the swab she noticed that the tip of the applicator was missing.Per the customer she experienced pain and shortness of breath and called 911.The customer was able to remove the tip of the swab by standing over her sink and coughing forcefully.Per the customer she did not go to the hospital but did see an ent after the issue occurred.The sample has been requested but has not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer on (b)(6) she was providing care for her tracheostomy stent with the cotton tip applicator when the tip broke off into the customer's trachea.

• Type of Device: APPLICATOR,COTTON-TIP,WOOD,6,STRL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15455269
• MDR Text Key: 300241071
• Report Number: 1417592-2022-00171
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS202000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Female