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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Sample rolls of durapore¿ advanced surgical tape (1590-0; lot number 2021-05 pa & 1590-1, unknown lot number) were received from the customer.The rolls of tape were tested and shown to meet all specification requirements.A batch record review for the subject lot confirmed no quality related deviations.Retest results of retain sample also showed that the tape meets the performance properties.A root cause could not be identified.Unplanned extubations (ues) are adverse events occurring in mechanically ventilated patients.Premature dislodgement of the endotracheal tube (ett) by the patient or staff is a more common event among pediatric and neonatal populations.The occurrence rates in the literature for critically-ill pediatric patients are not as consistent, however risk factors are nearly identical.Agitation and restlessness due to the minimal use of sedatives or muscle relaxants, ett fixation challenges, use of cuff-less etts, environmental conditions like high humidity, copious secretions, the potentially longer duration of intubation than in adults, and physical manipulation of the patient from repositioning, kangaroo care, general nursing care, and during procedures all contribute to an increased potential for unplanned extubation in the nicu and picu (pediatric intensive care unit) populations.

Event Description

A nurse reported an infant's endotracheal tube (ett) was secured with 3m¿ durapore¿ advanced surgical tape.The tape was found lifting off the infant's upper lip and re-taping was required.When the tape was removed, fraying occurred at the tape edges.During re-taping, the infant experienced a bradycardic episode with desaturation and required ppv (positive pressure ventilation) for 15 seconds.The infant quickly recovered, breath sounds were clear and equal bilaterally and good air entry was noted.

• Brand Name: 3M DURAPORE ADVANCED SURGICAL TAPE.
• Type of Device: 3M¿ DURAPORE¿ ADVANCED SURGICAL TAPE.
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH; edisonstrasse 6, 59174; kamen, ; GM
• Manufacturer Contact: dianne gibbs ; 3m center; 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8528534
• MDR Text Key: 142392417
• Report Number: 2110898-2019-00054
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOTRACHEAL TUBE
• Patient Outcome(s): Other
• Patient Age: 1 MO