MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067590
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original sample was not returned.Pictures of the fragment removed from the patient were provided.The pictures confirmed the piece to be a portion of the simpulse device.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.Based on the pictures provided, it appears the component may have fractured due to the forces applied to the device by the user during use.There is no way for us to conclusively identify what condition or combination of conditions were created to produce that force.A lot number was not provided, therefore, a review of the manufacturing records could not be performed.The information provided by bard 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 bard.Not returned for evaluation.
Event or Problem Description
It was reported that a simpulse solo was used on the patient to irrigate a left arm wound.The device was then discarded.One week later when the patient returned for an additional wound irrigation it was discovered that the tip had broken off of the previous device and was in the wound.The entire piece was retrieved and there were no fragments left behind.The patient did not show any adverse reaction to the detached piece and it was removed from the wound without additional medical or surgical intervention.The wound was then irrigated with no further issue.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7370688
• Report Number: 1213643-2018-00756
• Device Sequence Number: 69468
• Product Code: FQH
• UDI-Device Identifier: 00801741010132
• UDI-Public: (01)00801741010132
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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: 0067590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1