MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ PICC/CVC SECUREMENT DEVICE + TEGADERM¿ CHG DRESSING; 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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full product brand name: 3m¿ picc/cvc securement device + tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing lot number was not provided.Without a lot number, expiration date and manufacture date could not be determined.H-10 3m received information that the internal jugular catheter was inserted in the er and the dislodgement occurred in the icu.The dressing was reportedly "wet and bloody" when the event was discovered.Dressing application technique was unknown.The ifu states the following: do not use 3m¿ picc/cvc securement device where loss of adhesion could occur, such as with a confused patient, diaphoretic or nonadherent skin, or when the access device is not monitored daily.In addition, any active bleeding at the insertion site should be stabilized before applying the dressing.End of report.
Event or Problem Description
A physician alleged 1877-2100 3m¿ picc/cvc securement device + tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing did not secure an ij (internal jugular) catheter properly and a patient lost his line in the icu".The patient reportedly required reinsertion of their central catheter.

• Brand Name: 3M¿ PICC/CVC SECUREMENT DEVICE + TEGADERM¿ CHG DRESSING
• 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: 8256394
• Report Number: 2110898-2019-00013
• Device Sequence Number: 11271559
• Product Code: FRO
• UDI-Device Identifier: 30707387769469
• UDI-Public: 30707387769469
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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 Model Number: N/A
• Device Catalogue Number: 1877-2100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/17/2019
• 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