MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES CENTRAL LINE DRESSING

Model Number	77993D
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event is said to be available for evaluation but has not been received yet.Medical action industries is a repackager/relabeler of the complaint component, picns001, component lots jukw8209, jukt0417, jukw0277 purchased from specification developer, becton dickinson (fda registration number2243072).Supplier corrective action request (scar) was submitted to the manufacturer on april 7, 2026.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
During a picc line dressing change, the primary nurse encountered an issue with the statlock device when the prongs became stuck, rendering it unusable.As a result, the nurse completed the dressing without the statlock, obtained a new dressing kit from another unit due to lack of supply in the cicu, and redressed the line.The replacement kit also contained a statlock device that was difficult to operate, with doors that were hard to close and prongs that were challenging to adjust to fit the picc line wings.During the second dressing change the statlock was difficult to use and manipulate.Initially suspected to be a lot-specific issue, similar difficulties were observed in statlock devices from two different picc dressing kit lot numbers (346388 and 343567).There was a reported 60 min delay in completion of procedure; however, there was no patient adverse effects reported.

• Brand Name: CENTRAL LINE DRESSING
• Common Device Name: CENTRAL LINE DRESSING
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): BECTON DICKINSON; 1 becton dr; franklin lakes NJ 07417
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 24865713
• Report Number: 1030451-2026-00009
• Device Sequence Number: 13385231
• Product Code: PEZ
• UDI-Device Identifier: 20809160400897
• UDI-Public: 20809160400897
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 77993D
• Device Catalogue Number: 77993D
• Device Lot Number: 346388, 343567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown