MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SUBG ETT, PU CUFF, 8.0

Catalog Number	DYNJ18880
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient was undergoing an unspecified procedure and the doctor noticed a problem with a blown cuff on an endotracheal tube (ett).The facility reported that the incident occurred during the procedure and the patient had to be intubated again.The patient's o2 saturation decreased (levels not reported) and reintubation stabilized the patient.The customer returned the actual sample to medline for evaluation.During sample evaluation the customer reported issue of a blown cuff on an ett was confirmed however the cuff was not able to be inflated during evaluation due to the pilot tube appearing to be slit from possible external force resulting in a root cause that could not be definitively determined.No additional information is available at this time.There was no further intervention required for the patient.There was no follow-up medical care or additional medical intervention required related to the incident.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 or Problem Description
It was reported that the endotracheal tube had a blown cuff and a new endotracheal tube was required to be inserted.

• Common Device Name: SUBG ETT, PU CUFF, 8.0
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8898416
• Report Number: 1417592-2019-00123
• Device Sequence Number: 16534370
• Product Code: BTR
• UDI-Device Identifier: 10888277652712
• UDI-Public: 10888277652712
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ18880
• Device Lot Number: 59217111946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 88