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

Catalog Number 1837-2100

Device Problem Use of Device Problem (1670)

Patient Problem Confusion/ Disorientation (2553)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Customer stated picc/cvc securement device with dressing was placed on an elderly confused patient's subclavian catheter site.Customer reported patient's hand restraints were released during bathing and patient reached up and pulled out subclavian catheter.Customer reported picc catheter was inserted and no delay in therapy occurred.No additional patient details available.

Manufacturer Narrative

Conclusions: device not returned.No evaluation can be performed.Device not provided to manufacturer for evaluation.Complaint type is being monitored and analyzed.Following information provided on ifu package insert for 3m picc/cvc securement device + tegaderm i.V.Advanced dressing under warnings.

• Brand Name: 3M PICC/CVC SECUREMENT DEVICE + TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• Manufacturer (Section G): 3M; 3m center, 275-5w-06; st. paul MN 55144 100
• Manufacturer Contact: karen rittle, phd, mgr. ; 2410 conway ave.; st. paul, MN 55144 ; 6517330074
• MDR Report Key: 3632363
• MDR Text Key: 4205499
• Report Number: 2110898-2014-00011
• 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: 01/10/2014

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 AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention