MAUDE Adverse Event Report: 3M HEALTH CARE 3M PICC/CVC SECUREMENT DEVICE + TEGADERM I.V. ADVANCED SECUREMENT DRESSING; DEVICE, INTRAVASCULAR CATHETER SECUREMENT 880.5210

Catalog Number 1837-2100

Device Problem Use of Device Problem (1670)

Patient Problem Confusion/ Disorientation (2553)

Event Date 12/06/2013

Event Type  Injury  

Event Description

Customer states (b)(6) y/o female pt was receiving vasopressors through picc line.A 1837-2011 picc/cvc securement device + iv advanced dressing secured and covered the picc insertion site.Reports pt was confused and pulled out picc line along with the securement device and dressing.Reports patient required another central line and an internal jugular catheter was inserted.

Manufacturer Narrative

Method: device not received.Results: no evaluation performed.Conclusion: no evaluation can be performed.Device not provided to manufacturer for evaluation.Complaint type is being monitored and analyzed.Following info provided on ifu package insert for 3m picc/cvc securement device + tegaderm i.V.Advanced dressing under warnings: do not use 3m picc/cvc securement device + tegaderm i.V.Advanced securement dressing ("securement system") where loss of adhesion could occur, such as with a confused patient, diaphoretic or non adherent skin, or when the access device is not monitored daily.

• Brand Name: 3M PICC/CVC SECUREMENT DEVICE + TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT 880.5210
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE; 2410 conway avenue; st. paul MN 55144
• Manufacturer Contact: karen rittle phd regulatory mgr ; 3m center, 275-5w-06; st. paul, MN 55144-1000 ; 6517330074
• MDR Report Key: 3632364
• MDR Text Key: 4184867
• Report Number: 2110898-2014-00010
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 1837-2100
• Device Lot Number: 2015-05 AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• 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: 92 YR