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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M¿ MULTIPORE¿ DRY SURGICAL TAPE; 3M MULTIPORE DRY TAPE Back to Search Results
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 02/23/2022
Event Type  Injury  
Event Description
Extubation occurred for a neonatal patient on two different dates with use of 3m¿ multipore¿ dry surgical tape to secure an et tube to endotracheal tube holder.The tape was in place for twelve hours before the extubation occurred.The patient was reintubated after multiple attempts.The infant is still intubated.No skin preparations were used prior to application of the tape.There was humidity in the isolette.Three other incidents of this same problem of the tube slipping through the tape to a different position were alleged; case-specific information was not provided.
 
Manufacturer Narrative
The device was not available for return for analysis and no lot number was provided.There was humidity in the isolette.It is difficult to determine further that the cause of the incident is attributed to the 3m multipore dry surgical tape.
 
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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 Key13777393
MDR Text Key287249119
Report Number2110898-2022-00024
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/15/2022
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 NumberN/A
Device Catalogue Number3730-0
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2022
Initial Date FDA Received03/16/2022
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 Number1
Treatment
NEOBAR®
Patient Outcome(s) Required Intervention;
Patient Age1.5 WK
Patient SexFemale
Patient Weight1 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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