MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE; BHMC SYSTEM VAGINAL DELIVERY

Catalog Number	DYNJ34775J
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the x-ray gauze count in the pack was incorrect.The pack was expected to contain 10 units each of 4x4 and 4x8 x-ray gauze; however, a total of 21 gauze pieces were found between the two sizes.
Additional Manufacturer Narrative
It was reported that the x-ray gauze count in the pack was incorrect.The pack was expected to contain 10 units each of 4x4 and 4x8 x-ray gauze; however, a total of 21 gauze pieces were found between the two sizes.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.

• Brand Name: MEDLINE
• Common Device Name: BHMC SYSTEM VAGINAL DELIVERY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 6757
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25756631
• Report Number: 1423395-2026-00369
• Device Sequence Number: 10449358
• Product Code: MLS
• UDI-Device Identifier: 10198459343193
• UDI-Public: 10198459343193
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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: DYNJ34775J
• Device Lot Number: 26BLA916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown