MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ MULTIPORE¿ DRY SURGICAL TAPE; 3M MULTIPORE DRY TAPE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned and a lot number has not been provided.It is difficult to determine further that the cause of the incident is attributed to the 3m multipore dry surgical tape.

Event Description

An unplanned extubation occurred for a medically stable premature infant with use of 3m multipore dry surgical tape, where the tape was not staying secure.An endotracheal tube holder was used.The patient was reintubated immediately.There was no humidity in the isolette.No escalation of care was required.

• Brand Name: 3M¿ MULTIPORE¿ DRY SURGICAL TAPE
• Type of Device: 3M MULTIPORE DRY TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M JAPAN PRODUCT LIMITED; 5500 ooaza-osanagi; higashine-shi; yamagata, 999-3 737; JA 999-3737
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13502495
• MDR Text Key: 285396349
• Report Number: 2110898-2022-00015
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3730-0
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NEOBAR®
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 1 KG