MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING

Catalog Number	1683
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample or lot number has been received for this report.This customer reported they have been experiencing sporadic low adhesion with 1683 tegaderm iv advanced securement dressings.Report #2110898-2017-00112 was sent to the fda on 8sep17.In the initial report, the customer provided potential lot numbers for investigation by 3m.3m quality engineer investigated those lot numbers and no other complaints have been received for any of the lot numbers provided.For the first reported event, the customer also sent samples from their stock for evaluation.The samples were tested and the carrier, border and film adhesion were consistent with our product data for eto sterilized kits which would be processed through oem kit manufacturers.The customer provided additional information regarding a specific infant who experienced loss and subsequent replacement of their picc catheter on two different dates.The infant was reported as being very active and diaphoretic.Report numbers 2110898-2017-00132 and 2110898-2017-00133 were sent to the fda today to capture these reported events.The customer did not accept offers for a site visit from a 3m clinical representative for assessment and discussion of product application and facility protocol.
Event or Problem Description
A nurse reported a female infant experienced dislodgement of a peripherally inserted central catheter (picc) when a 1683 tegaderm iv advanced securement dressing was used for securement.The patient required a new picc line placement.

• Brand Name: 3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Common Device Name: TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 6901266
• Report Number: 2110898-2017-00132
• Device Sequence Number: 17683486
• Product Code: KMK
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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
• Operator of Device: Nurse
• Device Catalogue Number: 1683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Weight: 4