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

Catalog Number HA-005

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Reason for reoperation: "did not feel comfortable using this box of keller funnels as the box arrived unsealed".

Event Description

Healthcare professional reported " did not feel comfortable using this box of keller funnels as the box arrived unsealed.".

Manufacturer Narrative

Clarification to d.4: lot number 20g11c, expiration date 08/2022 clarification to h.4: 08/2020 device evaluation: a review of the device photos has been performed.The photo analysis revealed that seal on the package appear to be opened.Dhr review.No anomalies were identified in the dhr review which suggests that the issue indicated in this complaint was caused by a manufacturing defect.Visual inspection.The photo analysis confirmed that the seal appears to be opened.However, cannot confirm if this occurred at the cmo.

Event Description

Healthcare professional reported " did not feel comfortable using this box of keller funnels as the box arrived unsealed.".

• Brand Name: KELLER FUNNEL2 (5PK)
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 1239 se indian st; ste 112; stuart FL 34997
• MDR Report Key: 10830493
• MDR Text Key: 215965598
• Report Number: 3011299751-2020-00305
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HA-005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other