MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 QD PROBE TIP W/IRRIGATION HOLES; ND HYDRO-DISSECTION SYSTEM AND ACCESSORIES

Catalog Number	5539700
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during the case the nd probe tip did not fit onto the disposable piece and falls off.Hospital contact subsequently inspected the device and was able to attach the probe securely.The customer did not return the device for evaluation and retained the probe.The probe is reusable and will wear over time and can impact the ability of the device to secure.The instructions-for-use supplied with the device states: ensure that the probe tip is fully seated.Always inspect probe tips for damage.Do not use if damage is evident.Note, the date of event is considered to be best estimated as (b)(6) 2021 based on the reported event.Not returned.
Event or Problem Description
Customer reported that the reusable 10 mm irrigation qd probe tip did not fit onto the nd irrigation tubing set.It was reported that it falls off during the case.Contact reported that no patient harm has resulted, but that it also happened several weeks ago with a different 10mm tip.Alleged they did not hear or feel the indicative clicks that usually confirm the product is secure.The contact was unable to provide case specific details to know if the problem resulted in a possible detachment in use on the patient or if a fluid leak presented with this event.

• Brand Name: QD PROBE TIP W/IRRIGATION HOLES
• Common Device Name: ND HYDRO-DISSECTION SYSTEM AND ACCESSORIES
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12705619
• Report Number: 1213643-2021-20381
• Device Sequence Number: 19199252
• Product Code: GCJ
• UDI-Device Identifier: 00801741077081
• UDI-Public: (01)00801741077081
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 5539700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other