MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067730
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the purple tip of the bard/davol simpulse solo became detached and was removed from the surgical field.It is reported that the subject device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 360 units released for distribution in (b)(6) 2020.If/when sample is received and evaluation is completed, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
As reported, during a total knee arthroplasty (tka) procedure on (b)(6) 2021, the purple part tip of the bard/davol simpulse solo became detached and fell into the patient¿s body; all pieces were removed from the patient.There was no reported patient injury.
Event or Problem Description
As reported, during a total knee arthroplasty (tka) procedure on (b)(6) 2021, the purple part tip of the bard/davol simpulse solo became detached and fell into the patient¿s body; all pieces were removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the purple tip of the bard/davol simpulse solo became detached and was removed from the surgical field.It is reported that the subject device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december 2020.Addendum: this is an addendum to the initial mdr submitted to document the results of sample evaluation.The subject device is returned for evaluation.Visual evaluation of the sample confirms the showerhead body detached during use.There is no physical damage and no signs excessive force was applied to the tip.Visual evaluation finds little to no cyclohexanone.Based on the sample evaluation and investigation performed, the showerhead body is found to have detached from the irrigation tube due to the lack of cyclohexanone that adheres the spray tip to the irrigation tube; the root cause is found to be manufacturing related.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: sample evaluated.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11821261
• Report Number: 1213643-2021-20115
• Device Sequence Number: 17080800
• Product Code: FQH
• UDI-Device Identifier: 00801741010323
• UDI-Public: (01)00801741010323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 09/28/2025
• Device Catalogue Number: 0067730
• Device Lot Number: JUEX3824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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