MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PICC LINE PACK

Catalog Number	DYNJ65944A
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scissors in the picc pack not cutting effectively.
Additional Manufacturer Narrative
The account reported finding dull scissors in the picc pack.A photo and a sample were received; two photos and one sample of the scissors inside a biohazard bag were received, the rest of the pack was not received, and medline tested the sharpness of the scissors by cutting through the cloth material of the blue towel and the back table cover with no resistance.Based on the information provided and with the physical sample received, medline could not confirm the reported issue.No visual defects were observed, the component functioned as designed, and medline could not determine the true root cause for the reported issue.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-PICC LINE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50895953
• Report Number: 1417592-2026-50678
• Device Sequence Number: 12262324
• Product Code: OFF
• UDI-Device Identifier: 40193489478564
• UDI-Public: 40193489478564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: DYNJ65944A
• Device Lot Number: 22IBS600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown