MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SOFT SPLASH SHIELD W/ SHOWERHEAD TIP; LAVAGE, JET

Catalog Number	0067730
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was reported as available for evaluation; however, has not been returned to date.Based on the available information and without a sample to evaluate, we are unable to determine what may have caused the tip to have detached during the case.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional event and/or evaluation information is obtained, this report will be updated.
Event or Problem Description
It was reported by the user facility that the inner purple tip on the simpulse solo splashshield tip allegedly detached intra-operatively.Additional information was requested.There was no patient injury or complication reported.
Additional Manufacturer Narrative
The subject product was returned for evaluation.There was a piece of the irrigation connector tube securely bonded into the showerhead tip body.The irrigation connector tube had fractured just below the bonded joint.No material from the irrigation tube or showerhead tip was found to be missing.The component fractured due to the forces applied to the device during use.A review of the manufacturing records was performed and found that the lot was manufactured to specification.
Event or Problem Description
It was reported by the user facility that the inner purple tip on the simpulse solo splashshield tip allegedly detached intra-operatively.Additional information was requested.There was no patient injury or complication reported.

• Brand Name: SOFT SPLASH SHIELD W/ SHOWERHEAD TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8380138
• Report Number: 1213643-2019-01210
• Device Sequence Number: 16865762
• Product Code: FQH
• UDI-Device Identifier: 00801741010323
• UDI-Public: (01)00801741010323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 10/28/2022
• Device Catalogue Number: 0067730
• Device Lot Number: JUBYF578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1