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

Catalog Number	DYNJ82937
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported that "the units have wasted 4 packs so far because the packs are stuck on the tape that is supposed to secure the bottom of the boxes.When they pull them out, the packs are getting damaged and are no longer sterile.".
Additional Manufacturer Narrative
The account reported finding torn packs due to tape on the shipper carton, and the customer reported that packs were getting damaged and were no longer sterile when pulled out.A photo and a sample were received for investigation; the account sent in 4 packs for review, each pack had what looked to be snag marks and or holes on the pouch, and each one was tested with blue dye, which did not go through the pouch.Finished good production records and finished good pack build were reviewed, and no non-conformances or pack build issues were noted that would have contributed to the reported issue; the reported issue was not confirmed with the received sample.Based on the complaint details, the reported damage to the pack was strictly cosmetic and did not penetrate the pouch, and the division will monitor for trending.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-ARTERIOGRAM PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50734985
• Report Number: 1417592-2026-37090
• Device Sequence Number: 13416940
• Product Code: OEZ
• UDI-Device Identifier: 40195327224869
• UDI-Public: 40195327224869
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: DYNJ82937
• Device Lot Number: 22JBK214
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2023
• 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: 01/31/2023
• Initial Report FDA Received Date: 09/11/2026
• 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