MAUDE Adverse Event Report: ALLERGAN (KELLER) KELLER FUNNEL2 (1PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-001
Medical Device Problem Code	Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported via company representative "breast implant would not pass through funnel." patient contact did occur.
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.Reason for reoperation: "breast implant would not pass through funnel.".
Event or Problem Description
Healthcare professional reported via company representative "breast implant would not pass through funnel." patient contact did occur.
Additional Manufacturer Narrative
Sample investigation: no damage was observed.A coating evaluation was performed.For the interior surface, portions were observed to be lubricious and other portions were observed to not be lubricious.Since consistent lubricity was not observed, the expected result was not met.The exterior surface of the funnel was not observed to be lubricious, which meets the expected result.Despite observations made during the coating evaluation, a functional/ lubricity evaluation was performed to identify if there is sufficient lubrication to pass an implant through the funnel.During the functional/ lubricity evaluation, the breast implant could not be passed through the funnel.Since the breast implant was unable to pass through the funnel, no further attempt to pass the implant through was performed.The probable cause for the interior surface of the funnel to not be sufficiently lubricious is unknown; however, a manufacturing error is suspected.Abbvie device quality assurance (dqa) was notified of the condition of the sample.Per discussion and review with dqa, the current complaint sample is associated with keller funnel batch 24b42c.A recall for keller funnel batch 24b42c was initiated by formacoat.No further evaluation is required.Additional, changed, and/or corrected data.

• Brand Name: KELLER FUNNEL2 (1PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 1239 se indian st.; ste 112; stuart FL 34997
• Manufacturer (Section G): ALLERGAN (KELLER); 1239 se indian st.; ste 112; stuart FL
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7722199993
• MDR Report Key: 18445657
• Report Number: 3011299751-2024-00003
• Device Sequence Number: 20520975
• Product Code: KDD
• UDI-Device Identifier: 10888628043732
• UDI-Public: 10888628043732
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 06/14/2024
• 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: Female