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	09/30/2021
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 a best estimate as (b)(6) 2021 based on the information provided.
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.
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.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the product lot number.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Note, the date of event is considered to be a best estimate as 30-sep-2021 based on the information provided.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : 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
• Manufacturer (Section G): ATC TECHNOLOGIES -1225798; 30-b upton drive; wilmington MA 01887
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12705610
• Report Number: 1213643-2021-20380
• Device Sequence Number: 1467265
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5539700
• Device Lot Number: DAFHAT01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown