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

Model Number N/A

Device Problems Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, sex, ethnicity, race: information was not provided by reporter.Sample has not yet been returned for evaluation.Lot number was not provided.The tape was used to secure an endotracheal tube (brand unspecified) while the patient was at the neonatal station in an incubator at 30.5 degrees c and 45% humidity.The tape was used for approximately 24 hours prior to observation of the issue, and was reported to have stretched and lost adherence; adhesive was observed on the skin.

Event Description

Received from (b)(6): customer reported 3m¿ multipore¿ dry surgical tape that was used to secure an endotracheal tube for a (b)(6) old infant who was in an incubator in a neonatal station slipped, stretched and lost adherence approximately 24 hours after application.Adhesive was observed on the patient's skin.The tube was dislocated and re-taped several times before it was re-affixed with a non-3m brand tape.No extubation or patient injury occurred.

Manufacturer Narrative

Product samples were received from the customer.The samples were tested and met specifications for adhesion.

• Brand Name: 3M MULTIPORE DRY SURGICAL TAPE
• Type of Device: 3M MULTIPORE DRY TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; mn
• 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 ; 7379117
• MDR Report Key: 9825410
• MDR Text Key: 184050746
• Report Number: 2110898-2020-00016
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 34549395423560
• UDI-Public: 34549395423560
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3730-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 04/09/2020
• 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
• Patient Age: 3 WK
• Patient Weight: 1