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

Catalog Number	DYNJ68144B
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "particles in bowl or syringe.Now in the syringe when pulled up.".
Additional Manufacturer Narrative
The customer reported there was particulate that "settled in the bowl" and drawn into the syringe; the particulate did not come into contact with the patient and there was no patient involvement, serious injury, medical intervention, or follow up care.The account returned one syringe with a clear liquid inside, no other pack contents were received, finished good production records were reviewed, and finished good pack build was reviewed.While evaluating the received sample, medline observed a dark colored particulate floating around the clear liquid, confirming the reported issue.Due to the particulate being on the inside of the syringe and the syringe is received and remains inside of sterile packaging from the vendor, the root cause is considered to be a vendor product issue relating to the component manufacturing process; this complaint has been provided to the vendor for further evaluation and supplier quality will monitor this issue for trending purposes.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-HAND PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855782
• Report Number: 1417592-2026-47779
• Device Sequence Number: 13250141
• Product Code: OJH
• UDI-Device Identifier: 40195327174713
• UDI-Public: 40195327174713
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 09/22/2026

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: DYNJ68144B
• Device Lot Number: 24ABI312
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2024
• 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: 05/22/2024
• Initial Report FDA Received Date: 09/22/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown