MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; DBL DRAPE CENTRAL LINE KIT

Catalog Number	DYNDC3285
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility skin issues were reported with the dressing described as "wound with presence of slough at times".Per the facility "new wound care order placed, clean with antiseptic, pat dry, apply silvadene cream, cover with gauze and change dressing daily".Additional medical interventions were noted such as "removal of catheter and replacement on another site".At this time no additional event/patient specific details were provided related to the reported incident.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
"skin issues" under dressing.

• Common Device Name: DBL DRAPE CENTRAL LINE KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico, s. de r.l; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20169620
• Report Number: 3004519921-2024-00035
• Device Sequence Number: 7113404
• Product Code: LRP
• UDI-Device Identifier: 00653160358193
• UDI-Public: 00653160358193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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
• Device Catalogue Number: DYNDC3285
• Device Lot Number: 2024041790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown