MAUDE Adverse Event Report: PROXIMATE CONCEPTS LLC INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number IN-001

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Situation: a clean, non-sterile funnel labeled non-sterile training device, not for human use was received and used to introduce a breast implant into a patient.It failed/unzipped and was set aside after use on one side.The implant was placed in antibiotic solution, the site re-prepped and gowns and glovers were changed.Background: this product is an alternative for the keller funnel which is not available at this time.Staff here received an email with an email with an instructional inplant video.It is practice to inform staff when an alternative product is in the supply stream.Because of the funnel shortage, and to avoid waste associated with introducing funnels to the field when a case is set up, funnels are accessed and taken to the operating room just in time/ prior to use.Demo units are never received w/shipments.Assessment: the funnel was packaged in a peel pack and shipped with sterile funnels.The funnel had a warming printed on it, the peel pack did not.The usual barcode, lot # and expiration date were not on the peel pack.Inplant reported they send 6 sterile funnels per box, and a clean demo funnel outside of the box w/ the sterile funnels.Our purchase orders says 07/18 shipped, with hand written 8? on the packing slip.At this point of investigation, confirmation bias is why this was introduced for use on the patient, along w/just in time use, awareness of shortage, peel pack looked like it might have been a reprocessed item to the users.Recommendation: i have been in contact w/inplant.The other site in my company who uses this product was alerted.I have been in contact with the rep who provided me with inplant contact information.The implants were placed without funnels.The patient today, 01/13, the inplant team confirmed the funnel was clean, not sterile.It was labeled with warning- non sterile.They stated they routinely send a demo unit with orders and the packing slip includes notation of this, however i do not find a statement about including a demo unit in the shipment on the packing slip.We never expect to get a demonstration product with shipment of product for patient use.I also made contact with the rep who provided contact information for inplant to me.Fda safety report id # (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC; fort lee
• MDR Report Key: 9595953
• MDR Text Key: 175832484
• Report Number: MW5092272
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IN-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR