MAUDE Adverse Event Report: ALLERGAN (IRVINE) KELLER FUNNEL2 (5PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-005
Medical Device Problem Code	Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported "we were not able to pipe in the implant using keller funnel", "it appears that the inside of the funnel was not well lubricated.We couldn't even pipe the implant into a bucket without significant difficulty let alone pipe implant into patient's chest with small incision".It is unclear if there was patient contact.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: lubricity, inadequate lubrication.

• Brand Name: KELLER FUNNEL2 (5PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont dr.; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (IRVINE); 2525 dupont dr.; irvine CA 92612
• Manufacturer Contact: terry ingram ; 2525 dupont dr.; irvine, CA 92612 ; 0000000000
• MDR Report Key: 23405987
• Report Number: 3011299751-2025-00124
• Device Sequence Number: 11996955
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: (01)10888628043725(10)25A17C(11)250120(17)270120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: HA-005
• Device Lot Number: 25A17C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 01/20/2025
• 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