MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TRANSPORE¿ WHITE SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

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

Patient Problems Erythema (1840); Rash (2033); Blister (4537)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

A1, a4, e3: not provided.H10: a sample was not available for return for analysis.A lot number was not provided.It is not possible to definitively determine the root cause.3m will continue to monitor.

Event Description

Received from china: an infant who had come to the hospital due to a cough with sputum developed a red rash with blisters after an intravenous infusion of sodium chloride 100ml+ amoxicillin and potassium clavulanate 0.5g intravenous infusion where the infusion set was affixed with 3m transpore white surgical tape.The tape was discontinued, glucose 100ml+ dexamethasone 5mg intravenous infusion was administered, and the rash subsided and blisters improved about thirty minutes later.

• Brand Name: 3M¿ TRANSPORE¿ WHITE SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH WERK KAMEN; edisonstrasse 6; 59174 kamen; kamen, ; GM
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17283499
• MDR Text Key: 318643177
• Report Number: 2110898-2023-00063
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2023

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
• Device Catalogue Number: 1534-0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/07/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 10 MO
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian