MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a robotic hysterectomy procedure, the qd adapter of the bard/davol x-stream tubing set on the nd trumpet valve broke off during use.It was reported that the piece that broke off was retrieved and the or staff used a different device to finish the case.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol x-stream qd adapter on the nd trumpet valve broke off.The x-stream nd trumpet valve was returned for evaluation.Visual evaluation of the sample finds that the qc adapter is broken with a piece remaining screwed into the nd trumpet valve body.There were no manufacturing anomalies found.Overtightening the adapter or applying excessive side load to the tip during use or removing the nd tip at an angle could have resulted in breaking the qc adapter.Based on the sample evaluation and investigation performed, the most probable root cause is likely the result of forces applied while in use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in july, 2021.Note, the date of event is considered to be a best estimate as (b)(6) 2021 based on the date of awareness.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12828346
• Report Number: 1213643-2021-20424
• Device Sequence Number: 4571799
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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 Expiration Date: 06/28/2024
• Device Catalogue Number: 5552002
• Device Lot Number: JUFT0598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown