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

Catalog Number	HA-001
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 complaint: keller funnel had "hair on it".
Event or Problem Description
Healthcare professional reported ¿when they opened the packaging, keller funnel had hair on it.The funnel was not used¿.It is unknown if the device will be returned.
Additional Manufacturer Narrative
Return sample investigation/lab analysis: the category/subcategory of contamination - hair/ fiber on device is verified since what appears to be a hair was present in the sealed tyvek pouch upon complaint lab receipt of the sample.The probable cause for the presence of what appears to be a hair is unknown.Abbvie device quality assurance (dqa) was notified of the condition of the sample.An investigation object was created to capture abbvie analytical s&t lab investigation to characterize what appears to be a hair.An investigation object was created to capture additional investigation performed by command medical.No further evaluation by lake county complaint lab is required.Third party manufacturing investigation: the possible root cause was identified by the tpm to be a loose fiber from the cleanroom frock or employee clothing.There were no actions identified in the attached report.The tpm is considering the occurrence to be an isolated incident and will continue to monitor for trends.
Event or Problem Description
Healthcare professional reported ¿when they opened the packaging, keller funnel had hair on it.The funnel was not used¿.It is unknown if the device will be returned.
Additional Manufacturer Narrative
Device evaluation: no lot number provided from customer.Received customer analytical report gp0-mst-25-1416-inv determined by ftir-atr to be 100% polyester on (b)(6) 2025.Sample arrived (b)(6) 2025.Cmp blue gowns are made from 99% polyester and 1% carbon.Polyester, technically known as polyethylene terephthalate (pet), is a synthetic woven material derived from petroleum.Known for being incredibly durable, versatile, and relatively inexpensive to produce, polyester has become the most widely used fiber in the textile industry.¿ accounting for roughly half of the overall fiber market and around 80% of synthetics fiber.According to industry data, in 2018, polyester constituted 52% of global fiber production, amounting to 55 million metric tons produced annually.In 2020, global polyester fiber production increased to 57.1 metric tons.As there is no lot number associated with this complaint the dhr's for the last 4 lots of ha-001 were reviewed for loose particulate.Lots 23ko1c, 24b25c, 24h17c, 24h18c were reviewed and found to have correct line clearance records, all quality inspections ansi/asq z1.4 at an aql level of 0.65 passed with no defects noted.There were no non-conformance reports (ncmr) for these lots.One lot 24b25c was noted to have 12 rejects recorded in production for loose particulate.This was noted in reject recording section of inner and outer pouching.No further information was noted.Reviewed raw material lots (53248, 54167, 54168) for the inner pouch 028-mccppn7.255.87 and lots (53391, 54244) for the outer pouch 028-mcppn8.507.75 for non-conformance reports for particulate - no ncmr's were noted for these lots.Reviewed customer complaints of the last four years and there are no complaints noted for ha-001 (or ha 005) for loose particulate, hairs or fibers.Reviewed training for op 00.020, employee clothing, health and personnel practices which has the employee gowning process included - all personnel have been trained to this procedure.Conclusion: the possible root cause was identified by the tpm to be a loose fiber from the cleanroom frock or employee clothing.There were no actions identified in the attached report.The tpm is considering the occurrence to be an isolated incident and will continue to monitor for trends.Additional evaluation by abbvie analytical s&t was requested to identify the foreign material found within the sealed tyvek pouch.Conclusion: based on the results of the examination, both visual and instrumental, it can be concluded that the fiber was consistent with 100% polyester.
Event or Problem Description
Healthcare professional reported ¿when they opened the packaging, keller funnel had hair on it.The funnel was not used¿.

• Brand Name: KELLER FUNNEL2 (1PK)
• 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 drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23622579
• Report Number: 3011299751-2025-00137
• Device Sequence Number: 15716287
• Product Code: KDD
• UDI-Device Identifier: 10888628043732
• UDI-Public: 10888628043732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/24/2026

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
• 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): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 02/03/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025; 02/24/2026
• 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