MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING; TEGADERM¿ CHLORHEXIDINE GLUCONATE IV PORT DRESSING

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Reinfusion (2403); Needle Stick/Puncture (2462)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mw5078083 received from fda.End of report.
Event or Problem Description
A customer reported the following information via a medwatch report: accessed port on pediatric patient using the new tegaderm chg 3m dressing.Port was accessed and dressing applied as trained without complications.Patient medication started and was infusing via port.Stepped away from bedside to prepare next medication.Floor ma entered the med room and stated that the patient's port needle was out.As mom reported, went to the bedside and needle was out from the port injection site under 3m nonadhesive portion of the dressing.Needle laying against patient's chest.Quickly removed dressing and assessed site.Patient does have 3 red round marks that appear to be from the needle poking the skin under the nonadhesive portion.Called provider and updated on events.New order for medication was needed because the medication did not infuse as the needle was dislodged.Port site re-accessed using sterile technique dressing applied was not the chg dressing.Dressing applied was 3m adhesive tegaderm film 1624w.The details in the report is the extent to which we identify medications involved or patient contact.

• Brand Name: 3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING
• Common Device Name: TEGADERM¿ CHLORHEXIDINE GLUCONATE IV PORT DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7695351
• Report Number: 2110898-2018-00077
• Device Sequence Number: 19058473
• Product Code: FRO
• UDI-Device Identifier: 30707387770366
• UDI-Public: 30707387770366
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K123679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 1665
• Device Lot Number: 2019-11 AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: HUBER NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 MO
• Patient Weight: 11