MAUDE Adverse Event Report: 3M HEALTH CARE 3M DURAPORE ADVANCED SURGICAL TAPE.; 3M¿ DURAPORE¿ ADVANCED SURGICAL TAPE.

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient injury alleged.The sample was not returned by the customer for evaluation.A batch record review for the subject lot confirmed no quality related deviations.Issue review is open to determine root cause.
Event or Problem Description
A respiratory therapist in a pediatric intensive care unit reported that an infant's endotracheal tube (ett) was secured with 3m¿ durapore¿ advanced surgical tape.Application included duoderm® dressing on the patient's cheek under the durapore tape.The durapore tape was wrapped around the ett and attached to the patient's cheek.The same application was also completed on the opposite cheek.Tegaderm was then placed over the top of the duoderm® dressing and 3m¿ durapore¿ advanced surgical tape.An unknown skin prep/barrier film was used prior to application.The tape was exposed to oral secretions.The tape was reportedly found to be held together only by two white strands of the tape after the tape broke at the first wrap point around the tube.The infant was reported to be suctioned due to purple particles discovered in the back of the mouth and emergently re-taped.The respiratory therapist reported that the particles were aspirated, but no patient harm occurred.The patient's current status is extubated.The patient was reportedly extubated as a part of the hospitalization process.The patient did not require ventilatory support and was downgraded to c-pap/bi-pap.

• Brand Name: 3M DURAPORE ADVANCED SURGICAL TAPE.
• Common Device Name: 3M¿ DURAPORE¿ ADVANCED SURGICAL TAPE.
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9285009
• Report Number: 2110898-2019-00129
• Device Sequence Number: 16627945
• Product Code: KGX
• UDI-Device Identifier: 04054596475663
• UDI-Public: 04054596475663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 1590-1
• Device Lot Number: 2021-07 AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR