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

Catalog Number 1837-2100

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Customer reported diaphoretic patient had a triple lumen central catheter placed in right internal jugular.Reported picc/cvc device + dressing placed on catheter site.Reported nurse found device laying on patient's shoulder with catheter in device but not adhered to skin.Reported nurse had catheter pulled and replaced.No additional information available.

Manufacturer Narrative

Device not provided to manufacturer for evaluation.Complaint type is being monitored and analyzed.

• Brand Name: 3M PICC/CVC SECUREMENT DEVICE + TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE; 2410 conway ave.; st. paul MN 55144
• Manufacturer Contact: karen rittle, manager ; 3m center, 275-5w-06; st. paul, MN 55144-1000 ; 6517330074
• MDR Report Key: 3641028
• MDR Text Key: 4348521
• Report Number: 2110898-2014-00012
• 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: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• 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 AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2014
• 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