MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SCC VAGINAL PACK-LF

Catalog Number	DYNJ27133S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 8 vag packs come in that we cannot use bc the betadine exploded in the pack.
Additional Manufacturer Narrative
The account reported finding betadine leaked in pack.A photo and a sample were received for investigation; four unopen packs were received, pvp paint leaked in each of the four packs, there was no damage to the pvp bottles, production records had no non-conformances, and there were no issues with the pack build that might have an impact on the issue.The reported problem was confirmed based on the sample evaluation.Based on the component's location in the pack it is unlikely that placement contributed to the reported issue, and this complaint has been provided to the vendor for further evaluation while the supplier quality team 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-SCC VAGINAL PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50762965
• Report Number: 1417592-2026-39973
• Device Sequence Number: 9551228
• Product Code: OJF
• UDI-Device Identifier: 40195327112876
• UDI-Public: 40195327112876
• 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): 09/10/2026

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: DYNJ27133S
• Device Lot Number: 23DMD437
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2023
• 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: 07/16/2023
• Initial Report FDA Received Date: 09/14/2026
• 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