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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Irritation (2076); Reaction (2414)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu states the following: allow all preps and protectants to dry completely before applying the dressing to prevent skin irritation and to ensure good adhesion.Any active bleeding at insertion site should be stabilized before applying the dressing.It also states to inspect the dressing daily and change the dressing as as necessary.The dressing should be changed if it appears to be saturated or overly swollen*.*note: to test if the dressing is fully saturated, lightly press down on a corner of the gel pad with your finger.If the gel pad remains displaced once your finger is removed, the dressing should be changed.Note: tegaderm¿ chg gel pad is not designed to absorb large quantities of blood or fluid.
Event or Problem Description
A nurse reported an 1877-2100 3m¿ picc/cvc securement device + tegaderm¿ chg chlorhexidine gluconate iv securement dressing was applied to an inpatient's new picc insertion site.When the dressing was changed, seven days following application, the insertion site was reportedly red, hot and irritated.The picc catheter was removed due to skin condition.The nurse reported the patient required a new picc insertion.

• Brand Name: 3M¿ PICC/CVC SECUREMENT DEVICE + TEGADERM¿ CHG I. V. SECUREMENT DSG
• Common Device Name: PICC/CVC DEVICE + TEGADERM CHG DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7762439
• Report Number: 2110898-2018-00082
• Device Sequence Number: 19271848
• Product Code: FRO
• UDI-Device Identifier: 30707387769469
• UDI-Public: 30707387769469
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 1877-2100
• Device Lot Number: 2019-06 AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PREVANTICS® SKIN PREPARATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR